Atlas FDA

2002

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

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RecordFirmDate
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) (K020209)Dade Behring, Inc.2002-02-06
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER (K013723)Hitachi Medical Corp.2002-02-06
ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES (K013730)Novasys Medical, Inc.2002-02-06
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM (K014187)Boehringer Laboratories2002-02-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) (K020246)Dade Behring, Inc.2002-02-06
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (K020109)Sigma Diagnostics, Inc.2002-02-06
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT (K012621)Clearmedical, Inc.2002-02-06
R & D BODY FLUID CONTROL (K020229)R&D Systems, Inc.2002-02-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) (K020182)Dade Behring, Inc.2002-02-06
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY (K013717)Brentwood Medical Technology Corp.2002-02-06
MODIFICATION TO GEO STRUCTURE (K020048)Interpore Cross Intl.2002-02-06
FUKUDA DENSHI DYNASCOPE MODEL DS-5700 (K020084)Fukuda Denshi USA, Inc.2002-02-06
GENTLE COLONICS IRRIGATION SYSTEM (K002102)Gentle Colonics, Inc.2002-02-06
LOGIQ 3 (K020263)General Electric Co.2002-02-06
HANDHELD GAMMA FINDER (HGF) (K013751)Silicon Instruments Gmhb2002-02-06
CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH (K012601)Clearmedical, Inc.2002-02-06
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS (K014169)Bob J. Johnson & Assoc., Inc.2002-02-06
POWDERFREE LATEX SURGEON'S GLOVES (K013914)Kanam Latex Industries Pvt. , Ltd.2002-02-06
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE (K012606)Clearmedical, Inc.2002-02-06
CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR (K012616)Clearmedical, Inc.2002-02-06
DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM (K012439)Radco Data AB2002-02-06
OVUS CAPLESS SAFETY NEEDLE (K013006)Ovus Systems2002-02-06
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) (K020173)Dade Behring, Inc.2002-02-06
MARK 5000 QUADRATURE SHOULDER COIL (K013854)Usa Instruments, Inc.2002-02-06
CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE (K012612)Clearmedical, Inc.2002-02-06
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) (K020168)Dade Behring, Inc.2002-02-06
MICROLIGHT 830 LASER SYSTEM (K010175)Microlight Corporation of America2002-02-06
RIDIDFIX 2.7MM BTB CROSS PIN KIT (K013781)Mitek Products2002-02-06
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL (K012463)Everyway Medical Instruments Co.,Ltd2002-02-05
CANVAS N-VAS-D 2.0 (K014011)Vassol, Inc.2002-02-05
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT (K013891)Institut Straumann AG2002-02-05
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM (K020141)Ebi, L.P.2002-02-05
BECKER BAND CRANIAL REMOLDING ORTHOSIS (K013719)Becker Orthopedic Appliance Co.2002-02-05
CTL BODY / SPINE ARRAY COIL (K014086)Usa Instruments, Inc.2002-02-05
TRAPSYSTEM SET (K013692)H.S. Hospital Service S.R.L.2002-02-05
DYNA-LOK CLASSIC SPINAL SYSTEM (K020155)Medtronic Sofamor Danek2002-02-05
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274)Medtronic Physio-Control Corp.2002-02-05
ORTHOSIS HELMET MOLDING (K013700)Precision Prosthetics & Orthotics, Inc.2002-02-05
ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM (K020082)Endocare, Inc.2002-02-05
VASCUPUNCTURE ACCESS WIRE (K012861)Neometrics, Inc.2002-02-05
CENTRIFUGAL PUMP (K011838)Stockert Instrumente GmbH2002-02-05
ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM (K012549)Healthway Products, Inc.2002-02-04
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES (K014077)Shijiazhuang Great Vision Plastic Products Co., LT2002-02-04
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (K012676)Adven Medical2002-02-04
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013254)Top Quality Mfg., Inc.2002-02-04
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K012694)Adven Medical2002-02-04
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE (K013640)Pentax Precision Instrument Corp.2002-02-04
DEMETRON LC (K014179)Kerr Corp.2002-02-04
BERCHTOLD ELEKTROTOM 106 HITT (K013668)Berchtold Corp.2002-02-04
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (K020148)Phoenix Diagnostics, Inc.2002-02-04
VERAVIEWEPOCS, MODEL VE (K013955)J. Morita USA, Inc.2002-02-04
TEMPFIL (K013895)Sybron Dental Specialties, Inc.2002-02-04
MEDIGROUP CATHETER EXTENDER/REPAIR KIT (K012502)Janin Group, Inc.2002-02-04
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 (K013655)Nxstage Medical, Inc.2002-02-04
ENDO-GLIDE (K013701)Sonotech, Inc.2002-02-04
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS (K013885)Blackstone Medical, Inc.2002-02-01
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX (K013985)Machnet BV2002-02-01
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (K014016)Minntech Corp.2002-02-01
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) (K013511)Aculux, Inc.2002-02-01
MODIFICATION TO ISOBAR SPINAL SYSTEM (K020245)Scien'Tx USA, Inc.2002-02-01
SOFTIQUE, MODEL GI 11001 (K013707)Global TV Concepts, Ltd.2002-02-01
SPECTRAL'S TROPONIN I (K014105)Spectral Diagnostics, Inc.2002-02-01
BD VACUTAINER SAFETY COAGULATION TUBE (K013971)Becton, Dickinson & CO2002-02-01
ROCHE COBAS TAQMAN ANALYZER (K012966)Roche Molecular Systems, Inc.2002-02-01
TM2000, MODEL 1 (K013879)Card Guard Scientific Survival , Ltd.2002-02-01
DYONICS ELECTROBLADE RESECTOR (K012314)Smith & Nephew, Inc.2002-02-01
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) (K013826)Siemens Medical Systems, Inc.2002-02-01
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200 (K011901)Survivalink Corp.2002-02-01
VACUETTE EDTA K2 TUBES (K014104)Greiner Vacuette North America, Inc.2002-02-01
BIOTECH B990K VIVI WHEELCHAIR (K014198)Taiwan Armada Enterprise Co., Ltd.2002-02-01
TROJAN CRYSTAL CLEAR LIQUID (K013614)Armkel, LLC2002-02-01
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE (K020129)Phoenix Diagnostics, Inc.2002-02-01
MODIFICATION TO VIEWSEND MEDICAL (K013994)Klt Telecom, Inc.2002-02-01
SCANX (K013893)Air Techniques, Inc.2002-02-01
EXS-63 SMALL EXTREMITY ARRAY COIL (K020036)Mri Devices Corp.2002-02-01
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 (K020070)Progeny, Inc.2002-02-01
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE (K013611)Henke Sass Wolf of America, Inc.2002-02-01
SALTER LABS MODIFIED NEBUTECH NEBULIZER (K014056)Salter Labs2002-02-01
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 (K020022)Ge Medical Systems Information Technologies2002-02-01
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 (K012241)Cardionet, Inc.2002-02-01
MATRIX DETACHABLE COILS (K012985)Boston Scientific, Target2002-01-31
HUMPHREY OCT3 (K012727)Carl Zeiss Ophthalmic Systems, Inc.2002-01-31
GLOBALCARDIO (K013354)Cardiocomm Solutions, Inc.2002-01-31
NUCLEOTOMY INTRADISCAL CATHETER (K013622)Oratec Interventions, Inc.2002-01-31
APEX MEDICAL MINI TENS (K020032)Apex Medical Corp.2002-01-31
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (K020077)Augustine Medical, Inc.2002-01-31
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH (K014299)Sorba Medical Systems, Inc.2002-01-30
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) (K013752)Morgan Scientific, Inc.2002-01-30
DRG QUICKMIX (K011736)Doctor'S Research Group, Inc.2002-01-30
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM (K013196)Spinal Innovations, LLC2002-01-30
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (K012184)Blackstone Medical, Inc.2002-01-30
SLEEPBITE (K013808)Dental Imagineers, LLC2002-01-30
IDENT-A100 INTRAORAL VIDEO CAMERA (K013690)Confident Technology, Inc.2002-01-30
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH (K013824)Dental Manufacturing S.P.A2002-01-30
FINN CHAMBER (R) (K013820)Epitest Ltd. OY2002-01-30
PATRIOT PROTRUSIO CAGE (K020076)Biomet Orthopedics, Inc.2002-01-30
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS (K013617)Olympus Optical Co., Ltd.2002-01-30
MEDITRON II THESTERTHOSCOPE SYSTEM (K013725)Meditron AS2002-01-30
D.SIGN 53, MODEL NA1012204 (K014082)Ivoclar Vivadent, Inc.2002-01-30
SPIKED WASHER (K011583)Synthes (Usa)2002-01-30
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Every clearance here is in the API, with alerts when new ones post.