Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CERANUM 90 (K023198)Sb Lucius, Inc.2002-11-01
PLAYTEX BREAST PUMP (K022594)Playtex Products, Inc.2002-11-01
WIENER LAB. BILIRRUBINA TOTAL AA (K022962)Wiener Laboratories Saic2002-11-01
ULTRASOUND SCANNER, TYPE 1101 (K023457)B-K Medical A/S2002-11-01
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) (K022681)Azog, Inc.2002-11-01
K-FIX (K022597)New Deal, S.A.2002-11-01
THOMAS MEDICAL ELECTRODES (K022593)Thomas Medical, Inc.2002-11-01
MEDCOMP REPAIR KIT, MODEL ASPCRPK (K022570)Medcomp2002-10-31
FLASH 1 (K022583)Emed, Inc.2002-10-31
PERMACOL (K021056)Tissue Science Laboratories, Plc2002-10-31
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS (K020750)Everyway Medical Instruments Co.,Ltd2002-10-31
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM (K020689)Midi, Inc.2002-10-31
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS (K020749)Everyway Medical Instruments Co.,Ltd2002-10-31
KERADEC (K022663)Wieland Dental + Technik GmbH & Co. KG2002-10-31
OSSTAPLE, MAXILLOFACIAL (K023486)Biomedical Enterprises, Inc.2002-10-31
WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) (K023495)Welch Allyn, Inc.2002-10-31
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) (K023447)St Jude Medical2002-10-31
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT (K022638)Neurorecovery, Inc.2002-10-31
OSSTAPLE, CRANIOFACIAL (K023488)Biomedical Enterprises, Inc.2002-10-31
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL (K023307)Medical Analysis Systems, Inc.2002-10-31
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML (K023273)Becton, Dickinson & CO2002-10-31
NEWDEAL K WIRE (K022599)New Deal, S.A.2002-10-30
PHILIPS DIGITAL IMAGING OPTION RELEASE 1 (K023440)Philips Medical Systems2002-10-30
TRI-PLEX ADAPTER (K010401)The Medical Device Group, Inc.2002-10-30
NEW OUTLINE (K023079)Anaxdent GmbH2002-10-30
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES (K022060)Lumenis, Inc.2002-10-30
PHILIPS MULTIDIAGNOST ELEVA (K023441)Philips Medical Systems2002-10-30
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR (K022536)Fresenius Medical Care2002-10-30
MOISTURESTAY (REVLON) (K022626)Raymond Industrial, Ltd.2002-10-29
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP (K023471)Disetronic Medical Systems AG2002-10-29
EXPORT ASPIRATION CATHETER (K023303)Medtronic Vascular2002-10-29
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 (K020641)Worldwide Medical Technologies, LLC2002-10-29
TRAXX ELECTRIC WHEELCHAIR (K022194)Crossroads Distribution Company, LLC2002-10-29
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR (K022615)Centerpulse Spine-Tech, Inc.2002-10-29
1CC FUTURA SAFETY SYRINGE (K023323)Futura Medical Technology2002-10-29
PQ1 (K023042)Ultradent Products, Inc.2002-10-28
HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J (K023300)Guidant Corp.2002-10-28
TRUCATH.IP (K023368)Aortech Critical Care , Ltd.2002-10-28
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS) (K023262)Perusahaan Getah Asas Sdn. Bhd.2002-10-28
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT (K021541)Perkinelmer Life Sciences2002-10-28
ELITE MONOPHASE (K022653)Zhermack S.P.A.2002-10-28
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING (K022941)Abbott Laboratories2002-10-28
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED (K023343)Shanghai Palomar Mountain Industries, Inc.2002-10-28
ARTERIA OCCLUSION BALLOON (K021210)Arteria Medical Science, Inc.2002-10-28
IBOND GLUMA INSIDE (K022612)Heraeus Kulzer, Inc.2002-10-28
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE (K022589)ACON Laboratories, Inc.2002-10-28
KARATS MULTIPURPOSE SOLUTION (K021635)Ciba Vision Corporation2002-10-28
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (K021630)Boston Scientific Corp2002-10-25
RINGLOC CONSTRAINED LINERS II (K021728)Biomet, Inc.2002-10-25
SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET (K022477)Summit Medical , Ltd.2002-10-25
CLEARFIL AP-X PLT (K023002)Kuraray Medical, Inc.2002-10-25
COOK INJECTION NEEDLE (K022484)Cook Urological, Inc.2002-10-25
SPSMEDICAL SPORVIEW STEAM BI TEST PACK (K022706)Spsmedical Supply Corp.2002-10-25
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB (K023420)Medical Electronic Devices, Inc.2002-10-25
UTERINE INJECTOR (K022503)Thomas Medical, Inc.2002-10-25
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG, (K021186)Condomi Erfert Prodoktionsgesellschaft Mbh2002-10-25
MODIFICATION TO ESOP CO-CR FEMORAL HEADS (K023375)Pro-Active Healthcare2002-10-25
VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 (K022938)Volume Interactions Pte, Ltd.2002-10-25
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY (K022356)Nichols Institute Diagnostics2002-10-25
MEDCOMP VASCU-SHEATH INTRODUCER SET (K022513)Medcomp2002-10-25
RINGLOC CONSTRAINED LINERS (K021661)Biomet Orthopedics, Inc.2002-10-25
DFV CPG COLPOSCOPE (K021854)D.F. Vasconcellos S.A.2002-10-25
GALEMED NEB-EASY NEBULIZER (K021742)Galemed Corp.2002-10-25
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES (K022604)Sun Flower Gloves Co., Ltd.2002-10-25
ECHELON POROUS PLUS HA HIP STEMS (K023302)Smith & Nephew, Inc.2002-10-25
INCOMPASS SPINAL FIXATION SYSTEM (K021564)Spinal Concepts, Inc.2002-10-25
EBI XFIX DFS SYSTEM (K023399)Ebi, L.P.2002-10-25
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (K021976)Vital Scientific N.V.2002-10-25
REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002 (K022739)Nucletron Corporation2002-10-25
LEFORTE SYSTEM BONE PLATE (K023360)Jeil Medical Corporation2002-10-25
VARISOURCE BREAST TEMPLATE SYSTEM (K023220)Varian Medical Systems2002-10-25
HORIZONS REUSABLE POLYPECTOMY SNARES (K022268)Horizons Intl. Corp.2002-10-25
INFUSION CATHETER EXTENSION SET (K023224)Chf Solutions, Inc.2002-10-25
PHILIPS HARMONY RELEASE 1 (K022788)Philips Medical Systems North America Co.2002-10-25
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K023217)Cordis Corp.2002-10-25
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE (K023428)Shanghai Jiawang Industrial Co. , Ltd.2002-10-25
DR. JAPAN FACIL POINT SPINAL NEEDLE (K020934)Myco Medical, Inc.2002-10-25
HELIX HYDRO-JET (K022613)Erbe USA, Inc.2002-10-25
HORIZONS REUSABLE HOT BIOPSY FORCEPS (K022243)Horizons Intl. Corp.2002-10-25
SENSUA! (K021125)Aac Consulting Group, Inc.2002-10-25
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM (K020339)Dornier Medtech America, Inc.2002-10-25
VECTORVISION CT-FREE KNEE (K021306)Brainlab AG2002-10-25
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 (K021190)Roche Diagnostics Corp.2002-10-25
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES (K023475)Nihon Kohden America, Inc.2002-10-24
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (K023058)Seradyn2002-10-24
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 (K021689)Pan-America Hyperbarics, Inc.2002-10-24
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1 (K021693)Pan-America Hyperbarics, Inc.2002-10-24
CEDIA CYCLOSPORINE PLUS ASSAY (K023208)Microgenics Corp.2002-10-24
SPOT PRO (220V), MODEL 131.099 (K022741)Nucletron Corporation2002-10-24
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER (K023223)Lumend, Inc.2002-10-24
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS (K023182)Ethicon Endo-Surgery, Inc.2002-10-24
INRATIO SELF-TEST (K021923)Hemosense, Inc.2002-10-24
CLEARFIL AP-X PLT INTRO KIT (K022999)Kuraray Medical, Inc.2002-10-24
GYRUS ENT NERVE STIMULATOR (K021595)Gyrus Ent LLC2002-10-24
CARDIO ID+(RZ153+) (K022540)Rozinn Electronics, Inc.2002-10-24
E.CAM COMPUTER / E.SOFT WORKSTATION (K023190)Siemens Medical Solutions USA, Inc.2002-10-24
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM (K023194)Lifescan, Inc.2002-10-24
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 (K021690)Pan-America Hyperbarics, Inc.2002-10-24
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 (K020831)Roche Diagnostics Corp.2002-10-24
RANDOX APOLIPOPROTEIN CALIBRATOR (K023158)Randox Laboratories, Ltd.2002-10-24
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Every clearance here is in the API, with alerts when new ones post.