Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER (K871827)General Electric Co.1987-06-19
PREDICTOR (K871436)Corazonix Corp.1987-06-19
CANON SURGICAL AUTO KERATOMETER SK-1 (K871936)Canon USA, Inc.1987-06-19
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II (K872063)Hybritech, Inc.1987-06-19
OPHTHALMIC CANNULA (K872151)Pharmacia, Inc.1987-06-19
PMT TRACTION TONGS (K871663)Progress Mankind Technology1987-06-19
MORGAN THERAPEUTIC LENS (K871454)Mortan, Inc.1987-06-19
40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER (K864994)Aries Medical, Inc.1987-06-19
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA (K871605)Advanced Surgical Products, Inc.1987-06-19
UMSC HOLTER MONITORING KIT (K872087)United Medical Supply Co., Inc.1987-06-19
40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER (K864537)Aries Medical, Inc.1987-06-19
PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM (K872245)General Electric Co.1987-06-19
EASY READ(TM) (K871794)Health O Meter1987-06-19
KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS (K870066)Cascades Psh, Inc.1987-06-19
BT-795/ATS (K871847)Electromedics, Inc.1987-06-19
12.5MM PEYMAN WIDE FIELD YAG LASER LENS (K872136)Ocular Instruments, Inc.1987-06-19
DOTOLO COLON HYDROTHERAPY INSTRUMENT (K870534)Dotolo Research Corp. C/O Keller and Heckman1987-06-18
CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (K864610)Inframed, Inc.1987-06-18
GEM-CRIT CHECK (K871686)Diamond Sensor Systems1987-06-18
D-SCOPE II AND D-SCOPE IIC (K872127)Medx, Inc.1987-06-18
QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL (K872078)Solomon Park Research Laboratories1987-06-18
NEUROTIPS(TM) (K871571)Ulster Scientific, Inc.1987-06-18
SCX INFORMATION MANAGEMENT SYSTEM (K870400)General Electric Co.1987-06-18
FLEXIBLE BIOPSY FORCEP (K871809)Surgi-Aid Endoscopics, Inc.1987-06-18
KODAK EKTACHEM 700S ANALYZER (K872103)Eastman Kodak Company1987-06-17
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT (K871831)Diagnostic Products Corp.1987-06-17
DELFIA(TM) THYROXINE (T4) KIT (K871303)Lkb Instruments, Inc.1987-06-17
LINER OR GSRI-PNF (K871497)Gulf South Research Institute1987-06-17
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT (K872177)Nuclear Diagnostics, Inc.1987-06-17
ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG (K871449)Pa Medical Corp.1987-06-17
LYFO KWIK(TM) RUS KIT (K870731)Micro-Bio-Logics1987-06-17
UNI-FAST CREATINE KINASE TEST (CK) (K872029)Sclavo, Inc.1987-06-17
ACCULEVEL CARBAMAZEPINE TEST (K871254)Syva Co.1987-06-17
LIQUID TDM CONTROLS (K871788)Biological Industries1987-06-17
ADULT PERM-CATH 40CM. (K871749)Quinton, Inc.1987-06-17
ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT (K871620)Allelix, Inc.1987-06-17
BILATERAL CONTINUOUS PASSIVE MOTION DEVICE (K871981)Avec Scientific Design Corp.1987-06-17
DIGITAL FEVER THERMOMETER MODEL MC-5 (K871888)Omron Electronics, Inc.1987-06-17
TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER (K871892)Technicon Instruments Corp.1987-06-17
VAN-TEC REUSABLE HELICAL STONE BASKET (K871777)Van-Tec, Inc.1987-06-17
SAFESIDE(TM) LUMED (K871546)Luther Medical Products, Inc.1987-06-17
THEOPHYLLINE FPIA CONTROLS (K871589)Sigma Chemical Co.1987-06-17
NEO-I TEMPERATURE & CONDUCTIVITY METER (K871708)Automata, Inc.1987-06-17
SPIRASEAL(TM) FACE MASK (VARIOUS SIZES) (K872015)Brigam, Inc.1987-06-17
KODAK EKTACHEM 700P ANALYZER (K872104)Eastman Kodak Company1987-06-17
8000 SERIES GAS CHROMATOGRAPHS (K872122)The Perkin-Elmer Corp.1987-06-17
E.W.L. P-TENS/H-WAVE (K862121)Electronic Waveform Laboratory, Inc.1987-06-17
HELICAL STONE BASKET (DISPOSABLE) (K871779)Van-Tec, Inc.1987-06-17
PERM-CATH CATHETER KIT (K871942)Quinton, Inc.1987-06-17
ABBOTT SPECTRUM BICARBONATE REAGENT KIT (K872108)Abbott Laboratories1987-06-17
DYNATRON 438 (K870515)Henley Intl.1987-06-16
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING (K871166)Smith & Nephew, Inc.1987-06-16
FRASTEC DRY GAUZE BANDAGE (K871917)Fraass Survival Systems, Inc.1987-06-16
GUIDING CATHETERS 9F JL4 (K871021)Devices For Vascular Intervention, Inc.1987-06-16
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (K871549)Immunalysis Corporation1987-06-16
OVER DRAPE LEG HOLDER (K871900)Avec Scientific Design Corp.1987-06-16
FRASTEC DRY BURN DRESSING (K871916)Fraass Survival Systems, Inc.1987-06-16
MODEL 617 CARDIAC OUTPUT COMPUTER (K870375)Omnimed B.V.1987-06-16
LP-3 ELECTROCARDIOGRAPH (K864614)Fidelity Medical, Inc.1987-06-16
MASSTRON/MARQUEST MT-1000 GAS ANALYZER (K871253)Masstron C/O Burditt, Bowles & Radzius, Ltd.1987-06-15
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS (K872079)Reagents Applications, Inc.1987-06-15
MMG DELEE SUCTION CATHETER W/MUCOUS TRAP (K871949)Medical Technologies of Georgia1987-06-15
NASOPHARYNGEAL AIRWAY (K871673)Harding Industries, Inc.1987-06-15
MULTIPLE PHARMA-PLAST TRACHEAL TUBE (K871263)Pharma-Plast USA, Inc.1987-06-15
SP55 SYRINGE PUMP (K870330)Vickers , Ltd.1987-06-15
CHURCHILL-H VENTED IV SET W/METERING CHAMBERS (K871732)Churchill Corp.1987-06-15
IV PUMP SET (K871086)Churchill Corp.1987-06-15
SIEMENS DRY AIR COMPRESSOR (K871829)Siemens Elema AB1987-06-15
MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER (K871742)Health Products, Inc.1987-06-15
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125] (K871698)Immunalysis Corporation1987-06-15
BEAR JET VENTILATOR FOR USE DURING (ESWL) (K871985)Bear Medical Systems, Inc.1987-06-15
(MSI) PATH-SAVER (K872140)Medical Specialties, Inc.1987-06-15
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (K872056)Boots-Celltech Diagnostics, Inc.1987-06-15
TINA-QUANT [A] CRP (K871895)Boehringer Mannheim Corp.1987-06-15
ACUSYST-JR (K872086)Endotronics, Inc.1987-06-15
TINA-QUANT [A] TRANSFERRIN (K871896)Boehringer Mannheim Corp.1987-06-15
SENSIR SYSTEM (K870719)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-15
CIPRO (TM) DIAGNOSTIC POWDER (K872081)Miles Pharmaceuticals1987-06-15
IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) (K871596)Shiley, Inc.1987-06-15
MECONIUM ASPIRATOR (K871407)Intertech Resources, Inc.1987-06-15
MODEL TPC-1A OXYGEN ANALYZER (K872001)Medical, Inc.1987-06-15
CORNING DISPOSABLE ROLLER BOTTLES (K872076)Corning Medical & Scientific1987-06-15
RAICHEM(TM) SPIA(TM) APO B REAGENTS (K872080)Reagents Applications, Inc.1987-06-15
WH150 ROOM HUMIDIFIER (K871661)Associated Mills, Inc.1987-06-15
EXTENSION TUBE PUMP SET (K871085)Churchill Corp.1987-06-15
MCBRIDE MEDIUM CM 819 (K872135)Oxoid U.S.A., Inc.1987-06-15
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL (K871940)Kallestad Diag, A Div. of Erbamont, Inc.1987-06-12
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (K870840)Directed Energy, Inc.1987-06-12
DELFIA(TM) HIGE KIT (K871599)Lkb Instruments, Inc.1987-06-12
CARDIO-MEGA SYSTEM (K871890)Grandcor Medical Systems1987-06-12
VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH (K871488)Vas-Cath of Canada , Ltd.1987-06-12
CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (K871471)Travenol Laboratories, S.A.1987-06-12
K-GEL (K872128)Taro Pharmaceuticals, Inc.1987-06-12
EYEDENTITY EYEWEAR (K872062)Vitech Research C/O Johnsen, Manfredi & Thorpe1987-06-12
SIGMA'S CALCIUM PROCEDURE NO. 587 (K871152)Sigma Diagnostics, Inc.1987-06-12
TATCH-IT (K870356)Reunion Medical Co.1987-06-12
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS (K871685)American V. Mueller1987-06-12
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM (K871489)Diagnostic Systems Laboratories, Inc.1987-06-12
VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (K871487)Vas-Cath of Canada , Ltd.1987-06-12
PULSE CUFF RECORDER MODEL PCR100 (K863702)Imex Medical Systems, Inc.1987-06-12
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Every clearance here is in the API, with alerts when new ones post.