Atlas FDA

2002

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

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RecordFirmDate
HMS-DHR-3 NEUROMUSCULAR STIMULATOR (K021496)Home Medical Services2002-08-06
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045 (K022281)Polystan A/S2002-08-06
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 (K021974)Minimed, Inc.2002-08-06
STRYKER L3 HYDROLERT (K022248)Stryker Endoscopy2002-08-06
MOBILE MILLENNIUM MG SYSTEM (K022240)Ge Medical Systems, Inc.2002-08-06
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS (K022209)Alaris Medical Systems, Inc.2002-08-06
POLY STAT HCG DIPSTICK TEST (K021386)Alidex, Inc.2002-08-05
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K022434)C.R. Bard, Inc.2002-08-05
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER (K013704)Mediplus , Ltd.2002-08-05
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) (K021855)Top Glove Sdn. Bhd.2002-08-05
ELECSYS ANTI-TG TEST SYSTEM (K020672)Roche Diagnostics Corp.2002-08-05
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM (K001755)Mpw Industrial Water Services, Inc.2002-08-05
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (K021357)Porex Surgical, Inc.2002-08-05
DISETRONIC D-TRON INSULIN INFUSION PUMP (K021725)Disetronic Medical Systems AG2002-08-02
CRC-15BT (K020150)Capintec, Inc.2002-08-02
C.T.M. POWER CHAIR, MODEL HS-2800 (K021617)C.T.M. Homecare Product, Inc.2002-08-02
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220 (K020120)Boston Scientific Corp2002-08-02
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR (K022101)Latexx Manufacturing Sdn.Bhd.2002-08-02
BABY TEETHER, MODEL 20104 (K014023)Angelina Trading, Inc.2002-08-02
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS (K022317)Sooil Development Co., Ltd.2002-08-02
RELYX RMGIP (K022476)3M Company2002-08-02
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM (K022246)Depuyacromed2002-08-02
POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM (K012105)Symmetry Medical, Inc.2002-08-02
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, (K021455)Guidant Corp.2002-08-02
BONESOURCE HAC (K021440)Stryker Instruments2002-08-02
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES (K021950)Top Glove Medical (Thailand) Co., Ltd.2002-08-01
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS (K021352)Dayton Water Systems2002-08-01
CERALOY (K021971)Neirynck & Vogt NV2002-08-01
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM (K013093)Pall Medical2002-08-01
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (K021549)Std Mfg., Inc.2002-08-01
ESCAPE CONTROL MODULE (K021995)Specialty Drives Technologies, Inc.2002-08-01
ER150/M2 (K021456)World of Medicine Lemke GmbH2002-08-01
NORMED BONE TRANSPORT DISTRACTION DEVICE (K021341)Osteomedics, Inc.2002-08-01
UNINHIBITED (K021503)Bisco, Inc.2002-08-01
FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL (K021457)Pentron Corp.2002-08-01
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 (K022232)Cliniqa Corporation2002-08-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML (K021954)Becton, Dickinson & CO2002-08-01
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N (K022193)Ge Medical Systems Information Technologies2002-08-01
HERPESELECT 2 ELISA IGG, MODEL ELO920G (K021486)Focus Technologies, Inc.2002-08-01
XIA SPINAL SYSTEM (K022160)Howmedica Osteonics2002-08-01
PLUS PIVOT LINK UNIVERSAL SYSTEM (K021507)Spine Vision, Inc.2002-08-01
NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR (K021342)Osteomedics, Inc.2002-08-01
PERIFIX CATHETER CONNECTOR (K022019)B.Braun Medical, Inc.2002-08-01
DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E (K021853)Shanghai Antares Industries, Inc.2002-08-01
RUSCH EDGAR TUBE (K021540)Rusch Intl.2002-08-01
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE (K021452)Maxxim Medical2002-08-01
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) (K022024)Best Manufacturing Company2002-08-01
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM (K020040)Pt. Maja Agung Latexindo2002-08-01
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K012687)Vanguard Medical Concepts, Inc.2002-08-01
CLINPRO PROPHY POWDER (K021450)3M Espe AG Dental Products2002-08-01
ADVANTAGE WINDOWS X-RAY/MR FUSION (K022310)Ge Medical Systems, Inc.2002-08-01
STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA (K022162)Stryker Instruments2002-08-01
UNI-T UNI-THREAD SPINAL SYSTEM (K021510)Spine Vision, Inc.2002-08-01
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 (K022203)Abbott Laboratories2002-08-01
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES (K012693)Acutronic Medical Systems AG2002-08-01
ENVOY (K022168)Mennen Medical , Ltd.2002-08-01
POLAR WAND (K021387)Chek-Med Systems2002-07-31
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K012688)Vanguard Medical Concepts, Inc.2002-07-31
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA (K021482)Inova Diagnostics, Inc.2002-07-30
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE (K020042)Hycare Intl. Co., Ltd.2002-07-30
PROVOX FREEHANDS HME, MODEL 7710 (K022125)Atos Medical AB2002-07-30
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES (K021041)W.A. Rubbermate Co., Ltd.2002-07-30
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES (K014070)Zimmer, Inc.2002-07-30
CHROLOY (K021969)Neirynck & Vogt NV2002-07-30
VERDICT-II (K022141)Medtox Diagnostics, Inc.2002-07-30
TRACH VOX (K013728)Engineered Medical Systems2002-07-30
PANAG (K011891)Panag International2002-07-30
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT (K021231)Matritech, Inc.2002-07-30
TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT (K021264)Motion Concepts2002-07-30
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR (K021442)Oemedic International, Inc.2002-07-30
WU'S 4-WHEELED NEO SCOOTER, WT-L4 (K013763)Wu'S Tech Co., Ltd.2002-07-30
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 (K022355)Branan Medical Corp.2002-07-30
SELICOR, MODELS A100 & D100 (K020227)Selicor, Inc.2002-07-30
QUINCKE SPINAL NEEDLE (K022029)Epimed International, Inc.2002-07-30
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER (K022303)Philips Ultrasound, Inc.2002-07-30
TTECH MODEL 200E + TENS DEVICE (K021436)Theratech, Inc.2002-07-30
HI-OX (K020665)Sensor Medics Corp.2002-07-30
MODIFICATION TO EN-BLOC BIOPSY SYSTEM (K022296)Neothermia Corp.2002-07-30
REPROCESSED TROCARS AND CANNULAS (K012644)Surgical Instruments Service and Savings, Inc.2002-07-29
RESORBABLE CRANIAL CLAMPS (K021408)Synthes (Usa)2002-07-29
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 (K022200)Abx Diagnostics2002-07-29
ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE (K020657)Acculaser, Inc.2002-07-29
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (K013263)Fred Hutchinson Cancer Research Center2002-07-29
PSG INPUT BOX, MODEL JE-912AK (K022121)Nihon Kohden America, Inc.2002-07-29
MODIFICATION TO CARDEON AEGIS CATHETER (K022174)Cardeon Corp.2002-07-29
ADVANTAGE SIM 6.0 (K021780)General Electric Medical Systems2002-07-29
BD VACUTAINER PLUS PST II TUBE (K022130)Becton, Dickinson & CO2002-07-29
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (K021604)Ohio Medical Instrument Co., Inc.2002-07-29
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (K021194)Hemagen Diagnostics, Inc.2002-07-29
READI-STRAND; MODEL PSSTRAND (K020337)Worldwide Medical Technologies, LLC2002-07-29
MICROPLEX COIL SYSTEM (MCS) (K020434)MicroVention, Inc.2002-07-29
WISORB MALLEOLAR SCREW (K020222)Cambridge Scientific, Inc.2002-07-29
HERPESELECT 1 ELISA IGG, MODEL EL0910G (K021429)Focus Technologies, Inc.2002-07-29
ADMIRA SEAL (K021842)Voco GmbH2002-07-29
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K022161)Beckman Coulter, Inc.2002-07-29
ENDIUS TITLE SPINAL FIXATION SYSTEM (K021881)Endius, Inc.2002-07-29
CODMAN BACTISEAL EVD CATHETER SET (K021653)Codman & Shurtleff, Inc.2002-07-29
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET (K021757)Good Biotech Corp.2002-07-29
CHROLOY SOLDER (K021965)Neirynck & Vogt NV2002-07-26
FOSSA URETERAL STONE SWEEPER (K021602)Fossa Industries, Inc.2002-07-26
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Every clearance here is in the API, with alerts when new ones post.