Atlas FDA

2002

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

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RecordFirmDate
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A (K021179)Olympus Optical Co., Ltd.2002-07-05
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL (K021007)Tillotson Healthcare Corp.2002-07-05
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (K022018)Rhigene, Inc.2002-07-05
EMBRYO BIOPSY MEDIUM (K021358)Irvine Scientific Sales Co., Inc.2002-07-05
ULTRASONIC TIPS WITH DIAMOND COATING (K021253)Sybron Endo/Analytic2002-07-05
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (K021428)Bayer Corp.2002-07-05
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM (K021119)Wrp Asia Pacific Sdn. Bhd.2002-07-05
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) (K021730)Glovco (M) Sdn. Bhd.2002-07-05
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (K020818)Allegiance Healthcare Corp.2002-07-05
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 (K020475)Chad Therapeutics, Inc.2002-07-05
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO (K021919)Ortho Tec, LLC2002-07-03
LIGHT SABER SPINAL NEEDLE (K021084)Minrad, Inc.2002-07-03
INTROCAN SAFETY IV CATHETER (K021094)B.Braun Medical, Inc.2002-07-03
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK (K002741)Albert Browne , Ltd.2002-07-03
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA (K021332)Wiener Laboratories Saic2002-07-03
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES (K021407)Coalescent Surgical2002-07-03
CARESIDE LDH (K020484)Careside, Inc.2002-07-03
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A (K021453)Philips Medical Systems2002-07-03
AART PECTORALIS IMPLANT (K021337)Aesthetic and Reconstructive Technologies, Inc.2002-07-03
TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H (K021958)Bacchus Vascular, Inc.2002-07-03
FIBIOCORE (K020431)Est. Anthogyr2002-07-03
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L (K012600)Clearmedical, Inc.2002-07-03
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM (K021827)Roche Diagnostics Corp.2002-07-03
POLY-CHEM GLUCOSE (K020852)Polymedco, Inc.2002-07-03
POWERED MUSCLE STIMULATOR (K013768)Theratech, Inc.2002-07-03
CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 (K012609)Clearmedical, Inc.2002-07-03
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 (K021261)Galil Medical , Ltd.2002-07-03
MAC-LAB/CARDIOLAB EP/COMBOLAB (K021366)General Electric Medical Systems Information Techn2002-07-03
CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 (K012622)Clearmedical, Inc.2002-07-03
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM (K021159)Wrp Asia Pacific Sdn. Bhd.2002-07-03
CRANIAL STEREOTACTIC EQUIPMENT (K010065)Arplay Medical S.A.2002-07-02
DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 (K014255)Ge Medical Systems Information Technologies2002-07-02
IQ NASAL MASK, MODEL 50160 REV. D (K021534)Sleepnet Corporation2002-07-02
SAMPLOK LUER KIT (K021941)Itl Corporation Pty, Ltd.2002-07-02
AART MALAR IMPLANT (K021419)Aesthetic and Reconstructive Technologies, Inc.2002-07-02
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX (K021346)Wrightmedicaltechnologyinc2002-07-02
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (K013205)Millar Instruments, Inc.2002-07-02
INFINITI (K021566)Alcon Laboratories, Inc.2002-07-02
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM (K021830)Cobe Cardiovascular, Inc.2002-07-02
D/SENSE 1-STEP (K021146)Centrix, Inc.2002-07-02
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT (K021984)Inceptio Medical Technologies, LC2002-07-02
TRIDENT CROSSFIRE POLYUETHYLENE LINERS (K021911)Howmedica Osteonics Corp.2002-07-02
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 (K020386)Invacare Corp.2002-07-02
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER (K021124)Wfr/Aquaplast Corp.2002-07-02
Q LAB SOFTWARE (K021966)Advanced Technology Laboratories, Inc.2002-07-02
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM (K021829)Eastman Kodak Company2002-07-02
AART NASAL IMPLANT (K021418)Aesthetic and Reconstructive Technologies, Inc.2002-07-02
SSIR SYSTEM (K014208)Russian-American Technology Associates, Inc.2002-07-02
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) (K020021)Laserscope2002-07-02
CANDELA VBEAM PULSED DYE LASER SYSTEM (K021180)Candela Corp.2002-07-02
XIVE DENTAL IMPLANT SYSTEM (K021318)Friadent GmbH2002-07-02
RESPERATE; MODEL RR-150 (K020399)Intercure , Ltd.2002-07-02
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (K021961)Copioumed Intl., Inc.2002-07-02
RE-ENTRANT CHAMBER (K013689)Sun Nuclear Corp.2002-07-02
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES (K021521)Smart Glove Corp. Sdn Bhd2002-07-02
JUSTWO MODEL TME-601 ROOT APEX LOCATOR (K022020)Toei Electric Co., Ltd.2002-07-02
AART CHIN IMPLANT (K021417)Aesthetic and Reconstructive Technologies, Inc.2002-07-02
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 (K021824)Guidant Corp.2002-07-02
SCEPTRE-VS (K021314)Hitachi Medical Systems America, Inc.2002-07-02
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP (K021869)Diros Technology, Inc.2002-07-01
SMALL HAMMER TOE PIN (K021828)Biomet, Inc.2002-07-01
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) (K021349)Wrightmedicaltechnologyinc2002-07-01
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (K021317)Biosite Incorporated2002-07-01
GREAT TOE IMPLANT (K021063)Signal Medical Corp.2002-07-01
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735 (K021196)Neuron Therapeutics, Inc.2002-07-01
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES (K021165)Bromac Assistive Technology2002-07-01
VERTEBRAL SPACER (K011037)Synthes (Usa)2002-07-01
RUSCH FLONEIL; FLOCATH INTROGEL (K020714)Rusch Intl.2002-07-01
TRIPLE LUMEN CENTRAL VENOUS CATHETER (K013182)Cook, Inc.2002-07-01
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM (K021895)Bio-Logic Systems Corp.2002-07-01
O&P CRANICAL MOLDING HELMET (K021221)Orthotic & Prosthetic Lab, Inc.2002-07-01
BIOTOUCH MASSAGE THERAPY SYSTEM (K013061)Tactile Systems Technology, Inc.2002-07-01
PCCS GRAFT DELIVERY SYSTEM (K021071)Biomet, Inc.2002-07-01
LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE (K011220)Radiotherapeutics Corp.2002-07-01
BIOFASTIN RC THREADED SUTURE ANCHOR (K021883)Mitek Worldwide2002-07-01
MACROPORE OS TRAUMA (K021164)Macropore Biosurgery, Inc.2002-07-01
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM (K021825)Unitedstates Surgical2002-07-01
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB (K021831)Lacrimedics, Inc.2002-07-01
CARESIDE GGT (K020486)Careside, Inc.2002-07-01
ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX (K021079)Conmedcorp2002-07-01
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 (K021097)Spacelabs Medical, Inc.2002-06-28
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA (K020382)Medicotest A/S2002-06-28
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT (K021140)Fossa Industries, Inc.2002-06-28
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR (K020932)Sunrise Medical2002-06-28
SNORE SAT RECORDER, MODEL SS41 (K002159)Sagatech Electronics, Inc.2002-06-28
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM (K021943)Lifescan, Inc.2002-06-28
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 (K021229)Beckman Coulter, Inc.2002-06-28
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 (K021290)Vista Medical Technologies, Inc.2002-06-28
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K021345)Cordis Corp.2002-06-28
BODY FORCE, MODEL BT 6000 (K020211)Composites Solutions, Inc.2002-06-28
APEX MEDICAL DIGITAL EMS TS1311, TS1312 (K021754)Apex Medical Corp.2002-06-28
MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER (K021305)Microlife Corp.2002-06-28
WELCH ALLYN ABPM 6100 (K021756)Welch Allyn, Inc.2002-06-27
REPROCESSED ELECTROSURGICAL ELECTRODES (K012669)Surgical Instruments Service and Savings, Inc.2002-06-27
MILLENNIUM 5000 MEUROVASCULAR COIL (K021141)Usa Instruments, Inc.2002-06-27
ORS-1000LD (K021288)O.R. Solutions, Inc.2002-06-27
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM (K003720)Lifestream Purfication Systems, LLC2002-06-27
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR (K021535)Bayer Diagnostics Corp.2002-06-27
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR (K021532)Bayer Diagnostics Corp.2002-06-27
REX, VERSION 1.0 (K021099)Pointdx, Inc.2002-06-27
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Every clearance here is in the API, with alerts when new ones post.