Full listing of July 2008 Clearances of 510(k)s reprinted from "The Gray Sheet" - August 11, 2008
Includes clearances for Becton Dickinson & Co., Depuy Orthopaedics, Stryker Corp., Wright Medical Technology and more than 250 other top medical device companies. See what your competitors are doing.
FDA's July 2008 Clearances of 510(k)s Want more 510(k) clearance summaries? Subscribe to "The Gray Sheet" for regular updates. Start your free trial today. Contents copyrighted © F-D-C Reports, Inc. 2008; protected by U.S. Copyright Law.
The following 510(k)s were deemed "substantially equivalent" in July .(A) Indicates an abbreviated 510(k); (S) indicates a special 510(k); ** indicates that a 510(k) summary is available from FDA; * indicates that data are available from sponsor. 510(k)s are arranged alphabetically according to sponsor. Device descriptions are derived from FDA's database.
Company
510(k) Number
Device
Decision Date
AB Biodisk
K081325
Etest Doripenem - Antimicrobial Susceptibility Test*
7/24
Abbott Molecular
K080739
Realtime Ct/Ng Assay**
7/10
Abbott Research Group
K080200
Water Works Douching Device**
7/10
Accelerated Innovation
K080647
Accin Bipolar Head System**
7/8
Actigraph, LLC
K080545
Actitrainer**
7/24
Advanced Neuromodulation Systems
K081208
Cinch Anchor, Model 1194*
7/18
Affymetrix
K080995
Modification to Affymetrix Genechip Microarray Instrumentation*
7/30
Agendia Bv
K080252
Modification to Mammaprint**
7/21
Agfa Healthcare Corporation
K081963
Agfa Computed Radiography Systems with Nx2008 Workstations**
7/25
Agfa Healthcare Corporation
K081976
Impax Ma3000 Diagnostic Pacs Workstation**
7/28
Alfa Wassermann Diagnostic Technologies
K072143
S40 Clinical Analyzer, S Test Alb**
7/14
Allez Spine, LLC
K072678(S)
Laguna Size 8 Pedicle Screw**
7/2
Alma Lasers, Ltd.
K080463
Alma Lasers Thermoxel Co2 Laser System and Delivery Device**
7/23
Aloka , Ltd.
K081843
Ultrasound Data Analysis System, Model Das-Rs1**
7/15
Alphatec Spine
K081158(S)
Zodic Polyaxial Spinal Fixation System**
7/3
AMDL
K072901
ELISA Dr-70 (Fdp) Immunoassay, Model Dr2101**
7/1
Amplivox, Ltd.
K081841
Otowave 102 Hand Held Portable Tympanometer**
7/16
Ams S.R.L. Analyzer Medical System
K080468
Liasys with Models Liasys*
7/25
Andon Health , Ltd.
K073030
AG-605 Blood Glucose Monitoring System**
7/21
Andon Health , Ltd.
K080319
Kd-591 Fully Automatic Electronic Blood Pressure Monitor**
7/2
Andon Health , Ltd.
K080326
Kd-391 Semi-Automatic Electronic Blood Pressure Monitor**
7/31
Angiodynamics
K080287
Oncobionic Bipolar Electrode**
7/3
Angiodynamics
K080451
Uniblate Electrosurgical Device**
7/3
Appasamy Associates
K082031
Appasamy Slit Lamp, A1a-11 and A1a-12 Series**
7/31
Art Optical Contact Lens
K073621
Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifil**
7/3
Arthrocare Corp.
K081497(S)
Opus Magnum2 Knotless Fixation Device (Model Om-1502) **
7/28
Ascent Healthcare Solutions
K081238
Reprocessed Masimo Pulse Oximeter Sensors**
7/29
Ascent Healthcare Solutions
K081329
Reprocessed Electrophysiology Catheters**
7/9
Atrium Medical Corp.
K081718(S)
Express Chest Drain*
7/25
B-K Medical
K081323
Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy**
7/22
Barnev, Ltd.
K080672(S)
Birthtrack**
7/8
Becton Dickinson & Co.
K081446(A)
Spinal Needle, Models: 405081, 405235, 405236, 405237**
7/17
Beijing Choice Electronic Technology Co.
K081125(S)
Wrist Pulse Oximeter Md300w**
7/2
Biocomposites, Ltd.
K073341
Genex Putty**
7/9
Biolitec
K081015
Ceralas D 980nm Diode Laser, Models D15 and D25**
7/8
Biomet 3i
K080864
Cam Structsure Precision Milled Bars**
7/21
Biomet Manufacturing Corp.
K080426
Maestro Wrist Fracture Implant**
7/29
Biomet Manufacturing Corp.
K081172
Composite Hitch Suture Anchor**
7/17
Biomet Spine
K081501
Solitaire Anterior Spinal System**
7/2
Biomet Trauma
K081244
Lower Extremity External Fixation - Expanded Indications**
7/30
Biomet
K080642
Comprehensive Reverse Shoulder**
7/9
Bionostics
K081403
Glucose Meter-Check Control Solution for Roche Accu-Chek**
7/25
Blackstone Medical
K081177
Pillar Spacer System**
7/23
Boston Scientific Corp.
K080982
Sterling Es Monorail and Over-the-Wire PTA Balloon Dilatation Catheter**
7/14
Bovie Medical
K081431
Meg Laparoscopic Electrodes**
7/24
Braemar
K081444
Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring System*
7/31
Brennen Medical, LLC
K081272
Porcine Surgical Mesh; Dermal Matrix**
7/31
Busse Hospital Disposables
K080804(S)
Busse Plastic Lor Syringe**
7/9
C.R. Bard
K080668(S)
G2 Express Filter System-Femoral (Rf400f) and Jugular/Subclavian**
7/30
C.R. Bard
K081288
Aspira Peritoneal Drainage System**
7/18
Cagenix Inc.
K081157
Accuframe**
7/22
Carestream Health
K081836(S)
Dr Long Length Imaging System for Dr 7500 System*
7/30
CEC Electronica S.R.L.
K070888(A)
Combi 8 Max**
7/3
Ceremed
K081531
Aoc Soluble Implant Material**
7/18
Chad Therapeutics
K081176
Flochannel**
7/28
Chromogenex Technologies Limited
K081619(S)
Chromolite Ep**
7/18
Cianna Medical
K081677(S)
Savi Applicator Kit**
7/22
Classone Orthodontics
K080445
Lion Se One Step Orthodontic Adhesive**
7/16
Concentric Medical
K080583(S)
Modified Hd Guide Catheter**
7/18
Conmed Linvatec
K072291
Bio Mini-Revo Suture Anchor**
7/14
Cook
K081113
Central Venous Catheters**
7/30
Cook
K081690(S)
Spectrum Turbo-Jet Peripherally Inserted Central Venous Catheter**
7/14
Dade Behring
K081161
Dimension Vista System IgG Flex Reagent Cartridge**
7/28
Dade Behring
K081249
Dimension Vista System A2mac Flex Reagent Cartridge**
7/21
Danish Diagnostic Development A/S
K081829
Capimage**
7/11
Dentek Oral Care
K081669(S)
Improved Comfort-Fit Nightguard**
7/10
Depuy Orthopaedics
K080991
Asr Xl Modular Acetabular Cup System**
7/2
Draeger Medical
K072884
Fabius MRI**
7/30
Electrode Arrays
K071446(A)
Electrode Array Cap**
7/2
Electromedics, Ltd.
K073616
Fas-Clean Electrosurgical Coated Active Blade**
7/23
Elekta Neuromag Oy
K081430(S)
Elekta Neuromag with Maxwell Filter with Internal Active Shielding**
7/28
Ellex Medical Pty., Ltd.
K081565(S)
Integre Pro, Model L2ry**
7/2
Epitek
K080780
Anchorage Scope, Model 000003**
7/30
Esaote, S.P.A.
K081794
Model 7340 Ultrasound System**
7/10
Ethicon Endo-Sugery, LLC
K080972
Echelon Zebra Cartridges**
7/3
Flowcardia
K080849
Microsheath Lp and Lp-At**
7/25
Focus Diagnostics
K073382
Plexus Ebv IgG Multi-Analyte Diagnostics, Model: Mp0500g**
7/28
Fournitures Hospitalieres Industrie
K080974
Tls Fixation System**
7/1
GE Healthcare Finland Oy
K081870(S)
Masimo Compatible Saturation Module **
7/31
GE Medical Systems Information Technologies
K081437
Mac 1600 ECG Analysis System**
7/15
GE Medical Systems, LLC
K081916
Signa Mr Oncology Package**
7/22
Genadyne Biotechnologies
K080745
A4 Powered Suction Pump**
7/30
General Atomics
K072977
Diazyme Apolipoprotein A-1 Assay**
7/16
Global USA Distribution
K082033
Nannolight Intense Pulsed Light System**
7/31
Globus Medical
K080664
Relieve Laminoplasty Fixation System**
7/25
Globus Medical
K081391(S)
Vip Anterior Cervical Plate System**
7/3
GN Otometrics
K081234
Insert Earphones**
7/14
Gorbec Pharmaceutical Services
K073246
Zenieva**
7/23
Gyrus Acmi
K081954(S)
General Surgery Workstation**
7/31
H.C. Starck Ceramics
K081263(A)
Starceram**
7/1
Harvard Medical Devices
K081061
Ir Ear Thermometer*
7/18
Howmedica Osteonics Corp.
K081171
Tritanium Acetabular Shell System**
7/22
Howmedica Osteonics Corp.
K081284
Variax Distal Fibula Plate**
7/18
Hyperbaric America, LLC
K081506(A)
Presidential Monoplace Hyperbaric Chamber**
7/25
Ideal Life Inc.
K080538
Ideal Life Pod (Model Ilp 0001)**
7/3
Image Diagnost International, GmbH
K081630(A)
Mammo Workstation**
7/29
Image Stream Medical
K081698(A)
Mainstream or Surgical Light Control (Mslc)**
7/30
Implant Direct, LLC
K080633
Screwindirect Dental Implants**
7/15
Ingfertility, LLC
K072741
Pre-Va Vaginal Lubricant**
7/16
Inion Oy
K071810
Inion Spinal Graft Containment System*
7/11
Instrumentation Laboratory
K073042
Hemosil D-Dimer**
7/31
Interlace Medical
K081070
Operative Hysteroscopy System**
7/23
Iscience Interventional
K080067
Ophthalmic Microcatheter**
7/18
Isodose Control B.V.
K081112(A)
Flexiplan Brachytherapy Treatment Planning System**
7/29
It-V Medizintechnik, GmbH
K081218
Bellystep, Headstep, Breaststep, Prostep, Wingstep and Icast**
7/21
Italia Medica S.R.L.
K080220(A)
Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery*
7/28
Jiangsu Cureguard Glove , Ltd.
K081655
Powder-Free Vinyl Patient Examination Gloves (Light Yellow)**
7/21
Kavo America
K073074(S)
Key Laser III 1243 US with Detect**
7/10
Kera Harvest/Laser Max Medical Technologies
K080975
Fencer 308 Excimer Laser System*
7/15
KFX Medical
K081598(S)
Suture Lock Nail Bone Anchor**
7/3
Kimberly-Clark Corp.
K081089
Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves**
7/14
Kimberly-Clark Corp.
K081260
Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves**
7/9
KLS Martin, GmbH + Kg
K081678(A)
Conmed Beamer System C600**
7/29
KLS-Martin L.P
K080862
Sonicweld Rx (Resorb-X)**
7/21
Konica Minolta Medical & Graphic
K081637(S)
Laser Imager Drypro Model 873**
7/1
Koven Technology
K080178
Valvulotome By Koven**
7/28
Kuraray Medical Inc.
K081583
Clearfil Sa Cement**
7/28
Laborie Medical Technologies Corp.
K081781
Nuwav*
7/9
Larsen & Toubro Limited
K081552
Skyline 55**
7/31
Liposcience
K063841
Nmr Profiler and Nmr Lipoprofile Assay, Controls**
7/23
Live Tissue Connect
K071759
Ltc Vad System, Models #Vad.400 (Electrosurgical Generator); Pcs**
7/30
Lutronic Corporation
K080496
Mosaic Eco2 Laser System**
7/7
Materialise Dental Nv
K081402
Simplant Ortho ; Vistadent 3D**
7/18
Medela AG
K080212
Medela Thopaz, Model 200 0288**
7/23
Medela AG
K080357
Medela Invia Liberty, Model 200.1089**
7/24
Medi Nuclear Corp.
K080969
Healthline Redi-Neb Medication Nebulizer, Model Rn-510**
7/25
Medical Device Resource Corp.
K081593
Power Aspirator, Model Ls2 or Ls2dp**
7/23
Medical Technologies of Georgia
K080878
MTG Instant Cather (with and without Kit)**
7/17
Medicool
K073555
Insulin Protector**
7/11
Medison, Ltd.
K081676
Sonoace X6 Diagnostic Ultrasound System**
7/2
Medtrade Products, Ltd.
K080097
Celox Hemostatic Granules On Sheet**
7/9
Medtronic Navigation
K081512
Stealthviz Advanced Planning Application with Stealthdti Package**
7/18
Medtronic Sofamor Danek
K081950(S)
Progenix Plus**
7/18
Merete Medical, GmbH
K081513
Merete 3.0 and 3.5 Mm Locking Screws**
7/18
Metro Optics of Austin
K080512
Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens**
7/23
Microvention
K080666
Hydrosoft and Hydrosoft Plus Embolization Coil Systems**
7/11
Millennium Medical Technologies
K081039
Lipo Cannula*
7/10
Misonix
K070779
Sonatherm 600i Ultrasonic Lesion Generating System**
7/9
Mylad Orthopedic Solutions, LLC
K081356
Olecranail Intramedullary Fixation System**
7/9
Nakanishi
K073678
Variosurg*
7/10
Nashville Surgical Instruments
K081366
Kumar T-Anchors Hernia Set**
7/15
Neomed
K081515(S)
Dual Lumen Umbilical Catheter, Models S2uvc4.0, S2uvc5.0**
7/21
Northwind Technologies Corp.
K080695(A)
Mobile I.V. Systems 10, 20, 60**
7/1
Numed
K081680(S)
Nucleus-X, Model 230x**
7/10
NxStage Medical
K080807(S)
Blood Tubing Sets (Sterile Fluid Path)**
7/18
NxStage Medical
K081043
Leak Detection Sensor and Tray Accessory Kit**
7/7
OBS Medical
K081140
Visensia**
7/17
Olympus Terumo Biomaterials Corp.
K081561
Osferion D**
7/28
Omega Critical Care Limited
K081776(S)
Continuous Cardiac Ouput Monitor**
7/22
Orthopediatrics, Corp.
K081407
Pediplates System**
7/22
Osmetech Molecular Diagnostics
K073720
Esensor Warfarin Sensitivity and Xt-8 Instrument**
7/17
Osstem Implant , Ltd.
K080744
Hg II Fixture System**
7/17
Osstem Implant , Ltd.
K081078
Nt/It System**
7/15
Osteotech
K081227
Plexur M**
7/22
Osyris
K080731
Pharaon 980 Endo/Exo, Osyfibre 600, Control4+ Handpiece**
7/17
Pain Management Technologies
K073386
Joint Stim, Model 1000**
7/30
Paradigm Spine
K071668
Orthobiom Spinal System**
7/2
Pathway Medical Technologies
K081328
Pathway Pv Atherectomy System**
7/17
Pathwork Diagnostics
K080896
Pathwork Diagnostics Tissue of Origin Test**
7/30
Peak Surgical
K073057
Pulsar Generator, Model Ps100-100, and Peak Plasmablade**
7/22
Permobil AB
K081964
K450 Powered Wheelchair**
7/29
Philips Ultrasound
K081802
Cx50 Diagnostic Ultrasound System**
7/11
Physio-Control
K073089
Lifepak 20e**
7/29
Power Medical Interventions
K081826(S)
Intelligent Straight and Articular Endoscopic Linear Cutters**
7/25
Premier Dynamics
K080689
Spectra Therapy System A1000 Laser Device**
7/9
Preservation Solutions
K073693
Costorsol**
7/3
Q3 Innovations, LLC
K080848
Alcohawk Model Pt500 Digital Alcohol Detector**
7/25
Quantum Medical Imaging, LLC
K080905
Quantum/ Canon Cxdi Integration System, Model Qg-Dig-Cxdi**
7/16
Radi Medical Systems AB
K080813
Pressurewire Certus, Certus (300cm), Aeris, Aeris (300cm)**
7/1
Ramsey Medical
K072109(A)
Statmap, Model 7200**
7/31
Reliance Medical Systems, LLC
K081383(S)
Reliance Vbs System**
7/2
Reliant Technologies
K080915
Fraxel Re:Pair (Fraxel III Sr) Laser System and Accessories**
7/1
Resmed, Ltd.
K080797
Humidaire 2i**
7/9
Respironics
K081206
Homelox*
7/28
Response Biomedical Corp.
K063662
Ramp Nt-Probnp Assay**
7/21
Roche Diagnostics
K081389(S)
Accu-Chek Compact Plus Blood Glucose Monitoring System**
7/15
Roche Diagnostics Corp.
K080092
Elecsys Anti-Tshr Immunoassay**
7/28
Rochester Electro Medical
K080914(A)
Ultrasharp Concentric Needles**
7/15
Salter Labs
K080922
Oral/Nasal Thermal Airflow Sensor**
7/25
SDI, Ltd.
K081273
Ultracaps S*
7/10
Sebia
K080916(S)
Capillarys Urine*
7/1
Sendx Medical
K080370
Abl 80 Co-Ox System**
7/31
Serim Research Corp.
K081370
Serim Disintek Opa Test Strip**
7/11
Shenzhen Emperor Electronic Technology Co.
K081873
Emp-2100 Full Digital Ultrasound Diagnostic Device**
7/16
SHL Telemedicine International, Ltd.
K080047
Cardiosen'c**
7/11
Showa Ika Kohgyo , Ltd.
K071074
Mykres Spinal System**
7/2
Sialo Technology, Ltd.
K072334
Sialo Drain**
7/18
Siemens AG, Medical Solutions
K081734
Syngo Imaging (Version V31)**
7/3
Siemens Healthcare Diagnostics
K081300(S)
Dimension Vista Hdlc Flex Reagent Cartridge**
7/2
Siemens Healthcare Diagnostics
K081643(S)
Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent**
7/3
Siemens Healthcare Diagnostics
K081683
Loci Cardiac Troponin I Calibrator, Model Rc621**
7/7
Siemens Healthcare Diagnostics
K081294
Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein**
7/29
Siemens Healthcare Diagnostics
K081716(S)
Advia Centaur Havm Assay**
7/17
Signal Medical Corporation
K080199
Symmetric Total Knee System**
7/3
Signus Medical, LLC
K081108
Monopoly Pedicle Screw System**
7/14
Sintea Biotech
K081631(S)
PLS Multi-Axial Screws**
7/18
Smart Glove Corp.
K081466
Sterile, Powder-Free Nitrile Examination Gloves, Blue*
7/30
Smith & Nephew, Endoscopy Division
K081098
Endobutton Continuous Loop (Cl)**
7/16
Smith & Nephew
K080875(A)
Pigalileo 4th Generation System**
7/18
Smith & Nephew
K081111
Legion Hinge Knee System**
7/23
Smith & Nephew
K081124(A)
Mdf Revision Hip System**
7/31
Smith & Nephew
K081351(S)
Modification to Journey Unicondylar Femoral Implant**
7/24
Smiths Medical
K081229
Saf-T Closed Blood Collection System with Saf-Holder Device**
7/21
Smiths Medical
K081156
Cadd Medication Cassette Reservoir**
7/18
Soadco, S.L.
K080224
Klockner Essential Dental Implants System**
7/3
Solaris Medical Technology
K073249
Solaris Nt1 and Nt1a Handheld Pulse Oximeters with Sensor Access**
7/25
Sonoma Orthopedic Products
K080778
Ensplint Tm Bone Screw**
7/10
Sopro
K080122
670 Arthroscopic Pump**
7/11
Sorin Group Deutschland, GmbH
K080832(S)
Stockert S5 System, Stockert Gas Blender**
7/30
Spectra Medical Devices
K081524
Spectra-Lor, 10 Ml Plastic Loss of Resistance Syringe**
7/29
Spectros Corporation
K081233(S)
T-Stat 303 Ischemia Monitoring System**
7/28
Spinal Elements
K081418
Buttress Plate System**
7/14
SpineSmith Partners L.P
K080971
Cimplicity Spinal System**
7/2
SpineSmith Partners L.P
K081132
Cequence Anterior Cervical Plate System**
7/14
Spineworks, LLC
K081331
Fixxsure Cross Link**
7/23
SPS Medical Supply Corp.
K081879(S)
Sporview Pa Culture Set**
7/30
St. Jude Medical
K080292(S)
Epicor Ablation System**
7/25
Stanbio Laboratory
K081719(S)
Modification to Stanbio Laboratory Hemopoint H2 Hemoglobin System**
7/18
Streck
K080552
Cyto-Chex Bct**
7/31
Stryker Corp.
K080450
Power Tool Navigator Attachment**
7/17
Stryker Corp.
K082014(S)
Spine Avs Pl Peek Spacers**
7/28
Surgicraft, Ltd.
K072370
Surgical Mesh -#Cm, Size X, #, Length Guage, Instruments**
7/24
Surgrx
K081129
Enseal Powertip, Nseal-514d,-525d,-535d,-545d,-514rd,-525rd,-535r**
7/28
Synthes (USA)
K073115
Orthomesh**
7/15
Synthes (USA)
K073303
Norian Drillable**
7/2
Synthes (USA)
K081205
5.0mm/7.3mm Crimp Positioning Pins**
7/1
Synthes (USA)
K081353
Tomofix Medial Distal Femur Plates**
7/23
Synthes (USA)
K081452
Stainless Steel Elastic Intramedullary Nail System**
7/18
Synthes (USA)
K081700(S)
Sternal Fixation System - Line Extension**
7/17
Taidoc Technology Corporation
K081609(S)
Clever Chek and Audiochek Blood Glucose Monitoring Systems*
7/2
Taidoc Technology Corporation
K081714(S)
Fora Td-3224 Blood Glucose Plus Blood Pressure Monitoring System*
7/25
Talley Medical
K080897
Venturi Negative Pressure Wound Therapy System, Ts600v**
7/15
Tepha
K081099
Tephaflex Absorbable Suture**
7/15
Texas Infrared
K073581
Ici P and S Series Ir Cameras**
7/11
THD Spa
K081429
THD Slide**
7/30
The Phantom Laboratory
K081760
Rsvp Phantom Pelvis, Model Tlp260**
7/29
Theken Spine, LLC
K080822
Vu Apod Intervertabral Body Fusion Device**
7/2
Therapeutic Innovations
K071677
Srt II Muscle Stimulator**
7/11
Tornier
K081059(S)
Aequalis Reversed Shoulder Prosthesis**
7/17
Tornier
K081707(S)
Aequalis Shoulder Fracture and Shoulder Systems**
7/17
Totalgard Corporation
K072968
Stressgard Nightguard**
7/1
Trauson (Jiangsu) Medical Instrument Co.
K073159
Bone Screw, Models Ha 3.5 and 4.5**
7/23
Trinity Orthopedics, LLC
K081790(S)
Modification to Single Planar Multi Axis (Spma) Pedicle Screw System**
7/24
Ulrich Alber, GmbH
K080841
Cosmic System**
7/23
Vapotherm
K072845
Precision Flow**
7/17
Varian Medical Systems
K081188
Trilogy with External System Gating Interface**
7/14
Vascon, LLC
K053310
Roamer Microcatheter**
7/3
Vertebron
K081567(S)
Vertebron Ssp Cervical Plating System**
7/3
Vertebron
K081597(S)
Modification to Vertebron Pss Pedicle Screw System**
7/2
Voco, GmbH
K080814
Profluorid Varnish**
7/24
Vortek Surgical, LLC
K080341(A)
Endodrape**
7/21
W & H Dentalwerk Buermoos, GmbH
K080939
Surgical Handpieces, Mikro Saw Handpieces**
7/29
W.L. Gore & Associates Inc, Medica
K081184
Gore Viabil Bililary Endoprosthesis**
7/22
Wako Chemicals USA
K080123
Apolowako Hba1c, Glucose and Analyzer**
7/17
Wako Chemicals USA
K080125
Apolowako T-Cho, Hdl-C, Tg and Analyzer**
7/18
Well Lead Medical Instruments
K073383
Reinforced Endotracheal Tube**
7/10
Westmed
K081905
Accuflow and Accuflux Elastomeric Infusion Pump**
7/15
Wilfred Kromker, GmbH
K072136
Ultrasonic Nebuliser Model 2010**
7/15
Wright Medical Technology
K081373
Evolve Eps System**
7/3
WS Far IR Medical Technology
K080465
Ws Far Infrared Therapy Unit, Model # Ty-101 Series**
7/18
Xylos Corporation
K081882(S)
Modification to Xylos Surgical Mesh**
7/11
