Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CREATINE KINASE MB TEST ITEM NUMBER 5A46 (K914361)Em Diagnostic Systems, Inc.1991-12-13
DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR (K914917)E.I. Dupont DE Nemours & Co., Inc.1991-12-13
AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM (K912908)Air-Shields Vickers, Inc.1991-12-13
DRESSING/CVP DRESSING CHANGE/HYPERALIMENT TRAYS (K914157)Cml, Inc.1991-12-13
LIFESHIELD EXTENSION SET (K912103)Abbott Laboratories1991-12-13
INFLUENZA MAB TEST/INFLUENZA B TEST (K913214)Gull Laboratories, Inc.1991-12-13
MENTOR INFUSION LINE (K912919)Mentor Corp.1991-12-13
VIVUS PS (PROGRAMMING SOFTWARE) (K913907)I-Flow Corp.1991-12-13
ASCENTEC MEDICZAL SYSTEMS LAPAROSCOPIC ELECTRODE (K914252)Ascentec Medical Systems1991-12-13
MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2 (K912446)Vasamedics, LLC1991-12-12
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING (K913636)Cordis Corp.1991-12-12
LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM (K912165)Menlo Care, Inc.1991-12-11
ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH (K912532)Interventional Therapeutics Corp.1991-12-11
BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D (K913082)Respiratory Support Products, Inc.1991-12-11
DEVILBISS MODEL 7427D (K913316)Devilbiss Health Care, Inc.1991-12-11
DP 100 (K911192)Ferguson Medical1991-12-11
CHALLENGE 3000 NEUROLOGICAL BOOSTER (K903148)Maximum Performance Technologies, Mpts, Inc.1991-12-10
HEXLOCK (K912262)Imtec Corp.1991-12-10
RETRIEVAL DEVICE (K914067)Target Therapeutics1991-12-10
CHROMATOGRAPHY CLINICAL USE 75JQR (K914841)Millipore Corp.1991-12-10
ALBUMIN TEST RID KIT (K914391)The Binding Site, Ltd.1991-12-10
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE (K914181)Mill-Rose Laboratory1991-12-10
CR SPIRAL ELECTRODE (K910815)Neward Enterprises, Inc.1991-12-10
MEDTRONIC MODEL 90002065 MF TENS SYSTEM (K911963)Medtronic Vascular1991-12-10
MICRO EIA FOR COCAINE METABOLITES (K914533)Microdiagnostics, Inc.1991-12-10
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT (K913916)Smith & Nephew Richards, Inc.1991-12-09
PHENCYCLIDINE EIA ASSAY (K915179)Diagnostic Reagents, Inc.1991-12-09
CEDIA T4 (K915194)Boehringer Mannheim Corp.1991-12-09
RSV-MAB TEST (K912842)Gull Laboratories, Inc.1991-12-09
DEPUY (NITINO) GUIDE WIRE (K914693)Depuy, Inc.1991-12-09
NK PINCH SENSOR, MODEL PA001 (K914057)Nk Biotechnical Engineering Co.1991-12-09
3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA (K912099)3M Company1991-12-09
DANTEC MENUET (K912701)Dantec Medical, Inc.1991-12-09
TRANSFERRIN RID KIT (K914390)The Binding Site, Ltd.1991-12-09
DR. LIBERSON'S MICROPULSE NEUROMUSCULAR TRANS STIM (K912342)Amer Inst of Electrodiagnosis/Electrotherapy, Inc.1991-12-09
ORG-8200A UNIVERSAL SIGNAL HOUSING (K912744)Nihon Kohden America, Inc.1991-12-09
HAPTOGLOBIN IMMUNOLOGICAL TEST KIT (K913670)The Binding Site, Ltd.1991-12-09
C02 LASER WAVEGUIDE (K913887)Heraeus Lasersonics, Inc.1991-12-09
SPECTROLYSE PROTEIN C KIT (K914307)Biopool AB1991-12-09
PEDIATRIC VITRECTOMY LENS SET (K914051)Ocular Instruments, Inc.1991-12-09
POLLY'S CUTTER J-225 (K914038)O.R. Specialties, Inc.1991-12-09
DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) (K914245)Dale Medical Products, Inc.1991-12-09
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT (K913666)The Binding Site, Ltd.1991-12-09
F055 B.O. FANTASTIC RELAXER (K914707)Fairform Mfg., Co., Ltd.1991-12-09
RANGE OF MOTION SENSOR, MODEL RM001 (K914060)Nk Biotechnical Engineering Co.1991-12-09
F383 RECHARGEABLE MINI MASSAGER (K914703)Fairform Mfg., Co., Ltd.1991-12-09
NK RANGE OF MOTION SENSOR, MODEL RM002 (K914061)Nk Biotechnical Engineering Co.1991-12-09
SUCTION/IRRIGATION KITTNER (K914781)O.R. Concepts, Inc.1991-12-09
A101 LITESSAGER (K914830)Fairform Mfg., Co., Ltd.1991-12-09
FO92 SEATING MASSAGER (K914829)Fairform Mfg., Co., Ltd.1991-12-09
FO69 FANCY MASSAGER (K914704)Fairform Mfg., Co., Ltd.1991-12-09
MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA (K914043)Midwest Implant Sales, Inc.1991-12-09
FO51/F151 GOLF MASSAGER (K914706)Fairform Mfg., Co., Ltd.1991-12-09
CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE (K914850)Mast Immunosystems1991-12-09
STONE BASKET (K914505)Surgitek Medical Engineering Corp.1991-12-09
FO41 BODY MASSAGER (K914705)Fairform Mfg., Co., Ltd.1991-12-09
SUCTION/IRRIGATION PROBE (K914782)O.R. Concepts, Inc.1991-12-09
NK DEXTERITLY BOARD, MODEL BX001 (K914062)Nk Biotechnical Engineering Co.1991-12-09
ORTHODONTIC HEADGEAR (K912682)K-Tek Orthodontic Products1991-12-09
LATEX EXAMINATION GLOVES (K912040)Pt. Indoraya Everlatex1991-12-09
ESOPHAGEAL Z-STENT (K914029)Cook, Inc.1991-12-09
VIDENT IMPAC IMPLANT ACCESSORIES (K904391)Vident1991-12-09
MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT (K914041)Midwest Implant Sales, Inc.1991-12-09
PINCH SENSOR, MODEL PF001 (K914055)Nk Biotechnical Engineering Co.1991-12-09
NK GRASP SENSOR, MODEL GR001 (K914054)Nk Biotechnical Engineering Co.1991-12-09
MIDWEST IMPLANT HEXED 3.75MM SELF TAPPING IMPLANT (K914042)Midwest Implant Sales, Inc.1991-12-09
NK DEVIATION SENSOR, MODEL DV001 (K914059)Nk Biotechnical Engineering Co.1991-12-09
EMS300, EMS400, EMS8000 (K912642)Skylark Device Co., Ltd.1991-12-09
ULTRACROWN(TM) PRE-SOLDER (K914186)Dentsply Intl.1991-12-09
IMMUNOWELL DSDNA ANTIBODY TEST (K914801)General Biometrics, Inc.1991-12-09
FUKUDA DENSHI MODEL FCP-4101 (K913811)Fukuda Denshi USA, Inc.1991-12-09
IV 1000 INSUFFLATOR RAPID FLOW (K910983)M.D. Engineering, Inc.1991-12-09
SOMATOSENSORY STIMULUS SYSTEM (K913604)Biomagnetic Technologies, Inc.1991-12-09
NK PINCH SENSOR, MODEL PF002 (K914056)Nk Biotechnical Engineering Co.1991-12-09
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION (K914458)Medical Data Electronics1991-12-09
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM (K911661)Immuno Concepts, Inc.1991-12-09
SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG (K914089)Sharplan Lasers, Inc.1991-12-06
SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER (K914009)Schneider Intl., Ltd.1991-12-06
NK PINCH SENSOR, MODEL PA002 (K914058)Nk Biotechnical Engineering Co.1991-12-06
KINAMED CTN STEM (K914237)Kinamed, Inc.1991-12-05
PHILIPS P74P BEHIND-THE-EAR HEARING AID (K915252)Philips Hearing Instruments Co.1991-12-05
MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR (K914762)Micromed1991-12-05
BIOPSY ACCESSORIES FOR ULTRASOUND PROBES (K912088)Biosound, Inc.1991-12-05
ALPHATEC CANNULATED BONE SCREWS (K914004)Alphatec Mfg., Inc.1991-12-05
SYSTEM ATHENA - PRODUCT ENHANCEMENTS (K912049)S & W Medico Teknik1991-12-05
THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER (K913356)Monitor Instruments, Inc.1991-12-05
SCLEROTHERAPY NEEDLE (K914496)Surgitek Medical Engineering Corp.1991-12-05
ZARA ZONE IV MALAR IMPLANT (K914016)Byron Medical1991-12-05
REMOVE LABELING RESTRICT FROM GUIDE WIRES (K912293)Target Therapeutics1991-12-05
GRASPING FORCEPS (K914503)Surgitek Medical Engineering Corp.1991-12-05
OPOMAT MANUAL RESUSCITATOR VENTILATOR (K912620)Euro-Am Pharma, Inc.1991-12-04
EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER (K914810)Medica Corp.1991-12-04
SAFE II (K912082)Polystan A/S1991-12-04
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF (K914742)Medtronic Vascular1991-12-04
BANDAGE ROLL, GAUZE (K913779)Keilei Intl., Inc.1991-12-04
CMV-EA MAB TEST (K912592)Gull Laboratories, Inc.1991-12-04
PROMEON 63B SURGICAL TAPE (K914912)Promeon1991-12-04
ACS ULTRA-1 THROMBOPLASTIN (K913249)Analytical Control Systems, Inc.1991-12-04
VIADERM (K914024)Abs Life Sciences1991-12-04
MULTIPLE BURN DRESSING (K914071)Kerma Medical Products, Inc.1991-12-04
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.