Atlas FDA

2002

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

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RecordFirmDate
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 (K022574)Intuitive Surgical, Inc.2002-11-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K023301)Becton, Dickinson & CO2002-11-12
HAND DRILL, MODEL 11-9901-7 (K022712)Medical Design, LLC2002-11-12
ESSEX ENDOSCOPE, MODEL SXD-1000 (K023627)Guidant Corp.2002-11-12
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 (K023629)Guidant Corporation, Cardiac Surgery2002-11-12
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES (K023236)Maxxim Medical2002-11-12
KLARITY (K022708)Larson Products, Inc.2002-11-12
PNEUMOPERITONEUM INSUFFLATION NEEDLE (K021247)Mectra Labs, Inc.2002-11-08
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL (K023596)Medrad, Inc.2002-11-08
PRECLUDE MVP DURA SUBSTITUTE (K021477)W. L. Gore & Associates, Inc.2002-11-08
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES (K023590)Yty Industry (Manjung) Sdn Bhd2002-11-08
COLUMBUS TOTAL KNEE SYSTEM (CR) (K022672)Aesculap, Inc.2002-11-08
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER (K011471)Medtronic Functional Diagnostics A/S2002-11-08
SPERM CRYOPROTEC (K023206)Nidacon International AB2002-11-08
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS (K023409)Biomet, Inc.2002-11-08
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M (K021239)Eikon Healthcare Device Corp.2002-11-08
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 (K021240)Eikon Healthcare Device Corp.2002-11-08
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES (K022572)Ar Alliance Healthcare Sdn. Bhd.2002-11-08
PRIMAGARD SURGICAL EQUIPMENT DRAPES (K022868)Primeline Medical Products, Inc.2002-11-08
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY (K023398)Hologic, Inc.2002-11-08
STRYKER POWERED WHEELED STRETCHER (K022309)Stryker Corp.2002-11-08
PRIMAGARD SURGICAL GOWNS (K023266)Primeline Medical Products, Inc.2002-11-08
MODIFICATION TO VKS KNEE SYSTEM (K023416)Plus Orthopedics2002-11-08
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM (K023413)Neothermia Corp.2002-11-08
SUNPEX TECHNOLOGIES MODEL SE 01 (K021925)Sunpex Technology Co., Ltd.2002-11-08
PHILIPS M5066A AND M5068A (K020715)Philips Medical Systems2002-11-08
MODIFICATION TO GELBFISH VASCULAR DILATORS (K023507)Vascumetrix, LLC2002-11-08
PRIMAGARD SURGICAL GOWNS (K023117)Primeline Medical Products, Inc.2002-11-08
ECAT LSO PET/CT 16 (K023518)Cti Pet Systems, Inc.2002-11-08
FUNDUS AUTOIMAGER (K020888)Visual Pathways, Inc.2002-11-07
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE (K020003)Bio Protech, Inc.2002-11-07
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH (K022655)Trimedyne, Inc.2002-11-07
ARTHREX FIBERWIRE IN USP SIZES (K021434)Arthrex, Inc.2002-11-07
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL (K022675)Prime Dental Manufacturing, Inc.2002-11-07
SURETAC III, MODELS 7209900, 7209901 (K023417)Smith & Nephew, Inc.2002-11-07
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT (K023048)Beckman Coulter, Inc.2002-11-07
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' (K014218)Dolphin Medical, Inc.2002-11-07
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML) (K023458)Taiject Medical Device Co., Ltd.2002-11-07
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (K023039)Tuta Healthcare Pty Limited2002-11-07
PISTON SYRINGE & HYPODERMIC NEEDLE (K022159)International Medsurg Connection2002-11-07
CENTRICITY PACS PLUS (K023557)GE Medical Systems2002-11-07
ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS (K023631)Astra Tech, Inc.2002-11-07
ARCPM 1050 RESIN-HIPS (K023357)Biomet Orthopedics, Inc.2002-11-06
8F LAUNCHER GUIDE CATHETER (K023402)Medtronic Vascular2002-11-06
BIRD AVEA VENTILATOR (K022674)Bird Products Corp.2002-11-06
DRAPES WITH ABSORBENT REINFORCEMENT (K023425)Allegiance Healthcare Corp.2002-11-06
AMEDICA DRUG SCREEN THC TEST (K022955)Amedica Biotech, Inc.2002-11-06
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE (K023344)Bowel Management Systems, LLC2002-11-06
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS (K023350)Respironics California, Inc.2002-11-06
RETRO REPAIR KIT, MODEL PRRK5 (K022644)Spire Biomedical, Inc.2002-11-06
STERI-MATE STERILIZABLE HANDPIECE (K023697)Dentsply International2002-11-06
HEARTONE EVENT RECORDER AND TRANSMITTER (K023418)Aerotel Medical Systems (1998) , Ltd.2002-11-06
CO-AXIAL INTRODUCER NEEDLE (K022634)Promex, Inc.2002-11-06
AMEDICA DRUG SCREEN COCAINE TEST (K022954)Amedica Biotech, Inc.2002-11-06
AMEDICA DRUG SCREEN OPIATES TEST (K023047)Amedica Biotech, Inc.2002-11-06
WMT-TCP BONE GRAFT SUBSTITUTE (K022629)Wrightmedicaltechnologyinc2002-11-05
SIEMENS VIRTUAL SIMULATION (VSIM) (K022036)Siemens Medical Solutions USA, Inc.2002-11-05
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE (K020920)Cozart Bioscience , Ltd.2002-11-05
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 (K022610)Clarus Medical, LLC2002-11-05
BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 (K022643)Swemed Lab International AB2002-11-05
INSTANT-VIEW LH OVULATION PREDICTING TEST (K022829)Alfa Scientific Designs, Inc.2002-11-05
PROMOTOR (K023106)Ceres Fertility, Inc.2002-11-05
EXTRA LARGE BODY COIL (K023442)GE Medical Systems2002-11-05
THERMAGE THERMACOOL TC SYSTEM (K021402)Thermage, Inc.2002-11-05
CURAD (K022645)Beiersdorf AG2002-11-05
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS (K023586)Canon USA, Inc.2002-11-05
CERANUM 82 (K023197)Sb Lucius, Inc.2002-11-05
RANDOX C-REACTIVE PROTEIN CALIBRATOR (K022682)Randox Laboratories, Ltd.2002-11-05
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 (K023511)Toshiba America Medical Systems, In.C2002-11-05
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE (K023497)Datex-Ohmeda2002-11-04
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS (K022751)Medical Device Services2002-11-04
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES (K022007)Usa Instruments, Inc.2002-11-04
AUTOCON II 400 ELECTROSURGICAL GENERATOR (K021467)KARL STORZ Endoscopy-America, Inc.2002-11-04
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) (K023616)Ivy Biomedical Systems, Inc.2002-11-04
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS (K023569)Siemens Medical Solutions USA, Inc.2002-11-04
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 (K021576)Mercury Medical2002-11-04
CERANUM 76 (K023200)Sb Lucius, Inc.2002-11-04
HEMCON BANDAGE (K023298)Hemcon, Inc.2002-11-04
HYALURONIDASE SOLUTION (K022931)Irvine Scientific Sales Co., Inc.2002-11-04
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L (K022948)Medical Action Industries, Inc.2002-11-04
CERANUM 50 (K023199)Sb Lucius, Inc.2002-11-04
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT (K021732)Dideco S.P.A.2002-11-04
PHLEBOTEST 2000 (K022047)Osborn Medical Corp.2002-11-04
MEDLINE ASEP PLUS SURGICAL DRAPES (K023432)Medline Industries, Inc.2002-11-04
STEPHENS DISPOSABLE HOOKS (K022842)Stephens Instruments2002-11-01
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER (K023538)Medport, Inc.2002-11-01
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (K022021)Vital Scientific N.V.2002-11-01
CONTROL PLASMA N (K023309)Dade Behring, Inc.2002-11-01
PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US (K020886)Tyco Healthcare Nancy2002-11-01
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS (K011005)Pure Water Solutions, Inc.2002-11-01
LUCIUS 76 (K023196)Sb Lucius, Inc.2002-11-01
STEPHENS DISPOSABLE SPECULUM (K022836)Stephens Instruments2002-11-01
STEPHENS DISPOSABLE SCISSORS (K022840)Stephens Instruments2002-11-01
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT (K021551)Biocomposites, Ltd.2002-11-01
GAYHEART CORNEAL EXCISION DEVICE (K022843)Stephens Instruments2002-11-01
REGENECARE WOUND GEL (K020540)Mpm Medical., Inc.2002-11-01
STEPHENS DISPOSABLE FORCEPS (K022835)Stephens Instruments2002-11-01
SYNTHES LOW PROFILE NEURO SYSTEM (K022012)Synthes (Usa)2002-11-01
CONTROL PLASMA P (K023312)Dade Behring, Inc.2002-11-01
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) (K022680)Azog, Inc.2002-11-01
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Every clearance here is in the API, with alerts when new ones post.