Atlas FDA

1983

3,564 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI (K832124)Med-West, Inc.1983-08-12
AMPLATZ HEPARIN COATED CATHETER (K832178)Cook, Inc.1983-08-12
TRIANGLE BANDAGE STERILE (K831283)Pac-Kit Safety Equipment Co.1983-08-12
NAUTILUS MONOPLACE HYPERBARIC UNIT (K832127)Nautilus Environmedical Systems, Inc.1983-08-12
TWO-PLY PAPER FACE FACE MASK (K832281)Abco Dealers, Inc.1983-08-12
DISPOS. ABODOMINAL RETRACTING PAD (K831130)Product Development Corp.1983-08-12
AMRESCO NA/K REAGENT SET (K832070)American Research Products Co.1983-08-12
TRILEX (K831315)Tri-Med, Inc.1983-08-12
DERMALAND DURAL HOOKS (K832343)National Fabtronix, Inc.1983-08-12
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS (K832098)Syva Co.1983-08-12
BETA I PROGRAMMABLE INFUSION PUMP (K831897)Orange Medical Instruments, Inc.1983-08-12
BBL ANAGEL POWDER (K832229)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-08-12
LYSING REAGENT (K832182)Omega Medical Diagnostics1983-08-12
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY (K832139)Hybritech, Inc.1983-08-12
LIPASE REAGENT SET (K831874)Sterling Biochemical, Inc.1983-08-12
IVFLO-HP & IVFIL-HP FILTER (K831350)Tri-Med, Inc.1983-08-12
NOVA LIFT CHAIR (K832224)Nova Health Concepts, Inc.1983-08-12
INFUTROL 7000 INFUSION PUMP (K832008)Valleylab, Inc.1983-08-12
POLYCHACO INDIRECT HEMAGGLUTINATION (K830870)Parasitic Disease Consultants1983-08-12
DISP. TRANSDUCER W/MONITORING KIT TRANS (K831506)Sorensen Research1983-08-12
CARDIO-ESOPHASCOPE (K830716)Portex, Inc.1983-08-12
VARIOUS CARDIOVASCULAR SURGICAL DEVICE (K831769)Research Industries Corp.1983-08-12
PRESSURE MONITORING IV BOTTLE CAP (K831867)Alto Development Corp.1983-08-12
ELECATH BALTHERM TLC THERMAL DILUTION (K831945)Electro-Catheter Corp.1983-08-12
API UNISCEPT PLUS 140 INOCULATOR (K831462)Analytical Products, Inc.1983-08-12
GELIPERM DRY (K822073)Hamel, Park, Mccabe & Saunders1983-08-12
BIOCUFF INFUSION BAG PRESSOR (K832377)Bio-Medical Instruments , Ltd.1983-08-12
AQUALIZER MOUTHPIECE (K831793)Martin D. Lerman1983-08-12
P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT (K831396)Pudenz-Schulte Medical Research Corp.1983-08-12
HALL RECIPROCATOR (K832188)Amsco Co.1983-08-12
ACCES. HEAD CONTROL-POWERED CHEELCHAIR (K832321)Intl. Medical Equipment Corp.1983-08-12
LME TEMP. MONITOR (K832042)Litton Medical Electronics1983-08-12
VENIPUNCTURE VALVE (K832123)Abbott Laboratories1983-08-12
PHYSIOLOGICAL MONITOR #902 (K831578)Novametrix Medical Systems, Inc.1983-08-12
BONE SCREW (K831873)W. L. Gore & Associates, Inc.1983-08-12
HEARCO C (K831129)Hear Co., Inc.1983-08-12
URINE TOTAL PROTEIN CONTROL (K831526)Quantimetrix Corp.1983-08-12
INVAC W/VARIOUS MODELS (K831116)Pmt1983-08-12
CLEAR-RITE 3 (K832451)Richard-Allan Medical Ind., Inc.1983-08-12
RABBIT ANTI-HUMAN ANTITHROMBIN III (K832268)Gelco Diagnostics, Inc.1983-08-12
UNIPOLAR-E ENDOCARDIAL TINED LEAD (K832245)Cook Pacemaker Corp.1983-08-12
HALL OSCILLATOR (K832187)Amsco Co.1983-08-12
SUPRAMID EXTRA SURGICAL MESH (K831723)S. Jackson, Inc.1983-08-12
EXTERNAL VALVE FUNCTION BLOCK (K830914)Honeywell, Inc.1983-08-12
GAUZE SPONGE NON-STERILE (K832174)Sudreca Surgical Dressings, Inc.1983-08-12
CRYOMEDICS NEUROSTAT (K831963)Spembly Medical , Ltd.1983-08-12
GAUZE SPONGE STERILE (K832173)Sudreca Surgical Dressings, Inc.1983-08-12
CONVERTORS FLASH STERILIZING TRAY (K832137)American Convertors Div., American Pharmaseal1983-08-12
CAREFREE * PANTY SHIELDS-REG/DEOR (K832382)Johnson & Johnson Professionals, Inc.1983-08-12
INTRACARDIA SUCKERS (K831759)Research Industries Corp.1983-08-12
GAUZE BANDAGE (K831284)Pac-Kit Safety Equipment Co.1983-08-12
SNO STRIPS STERILE TEARFLOW TEST STRIP (K832181)Smith & Nephew, Inc.1983-08-12
EPCOM EMS-310 INTRAPARTUM MONITOR (K831113)Epcom Medical Systems, Inc.1983-08-12
INSPETOSCOPE (K831614)Terayco Intl., Ltd.1983-08-12
HEARING AID UNITRON #UE8-D (K831883)Unitron Industries, Inc.1983-08-12
CRYOMEDICS 5000 CRYOSURGICAL CONSOLE (K832334)Spembly Medical , Ltd.1983-08-12
RIM-HAEMOPHILUS 1 & 2 (K832051)Austin Biological Laboratories1983-08-12
GAUZE SPONGE X-RAY DETECTABLE- (K832172)Sudreca Surgical Dressings, Inc.1983-08-12
EPCOM EMS-320 REMOTE MONITORSCOPE (K831115)Epcom Medical Systems, Inc.1983-08-12
BIOELECTRICAL IMPEDANCE ANALYZER #101 (K830292)Rjl Systems, Inc.1983-08-12
PRP-1 REVERSED PHASE RESIN (K832197)Hamilton Co.1983-08-12
BLOOD PRESSURE MONITORING KITS,WALRUS (K830754)Medical Parameters, Inc.1983-08-12
BANDAGE COMPRESS (K831282)Pac-Kit Safety Equipment Co.1983-08-12
PROMINJET PUMP (K832120)Abbott Laboratories1983-08-12
GELIPERM GRANULES (K823225)Geistlich-Pharma1983-08-12
GAUZE COMPRESS (K831281)Pac-Kit Safety Equipment Co.1983-08-12
AMERI CLEAR (K832011)Stephens Scientific1983-08-12
BASE ONLY, TORONTO CHAIR (K832322)Intl. Medical Equipment Corp.1983-08-12
SC-603 TWIN VALVE (K831486)Instrumentation Industries, Inc.1983-08-12
MAXI SHIELDS (K831593)Weyerhaeuser Co.1983-08-12
OHIO MODEL 922 SPIROMETER (K832185)Airco/Ohio Medical Products1983-08-12
BASE ONLY, POWER WHEELCHAIR (K832325)Intl. Medical Equipment Corp.1983-08-12
XCEL MODEL XE-1 (K830992)Electrocaine Medical System1983-08-12
ORTHO ABNORMAL COAGULATION LEVEL I/II (K832225)Ortho Diagnostic Systems, Inc.1983-08-12
LIFELINE PACING LEADS #471-07 &09 (K832409)Intermedics, Inc.1983-08-12
ELECTRIC INSTRUMENT TABLE (K832073)CooperVision, Inc.1983-08-12
MODEL F UNIPOLAR ENDOCARDIAL LEAD- (K832255)Cook Pacemaker Corp.1983-08-12
SOPHEIA DIGOXIN EIA KIT (K832163)Diagnostic Products Corp.1983-08-12
AXIOM FEEDING GASTRO TUBE (K831823)Axiom Medical, Inc.1983-08-12
HC40/HC75 PREPACKED COLUMS (K832198)Hamilton Co.1983-08-12
ALLERGENETICS FLUORO-FAST READER (K831870)Axonics, Inc.1983-08-12
GONOCHEK PANEL (K830756)E-Y Laboratories, Inc.1983-08-12
SIMPLICITY PLUS (K831761)Critikon Company, LLC1983-08-12
CRYOMEDICS 5000 CRYOPROBES (K832140)Spembly Medical , Ltd.1983-08-12
CEILING MOUNTED SUPPORT (K831086)Amsco Co.1983-08-12
BAILEY ASPIRATOR/IRRIGATOR (K831584)Medical Instrument Development Laboratories, Inc.1983-08-12
PACELINE PATIENT TRANSMITTER MODEL 324 (K831443)Pacesetter Systems1983-08-12
READER MICROELISA SYSTEM (K831641)Organon Teknika Corp.1983-08-11
MORHEL CLOSED URINARY DRAINAGE SET (K831622)Morhel Mexicana1983-08-11
PARAMETRIC STERILITY RELEASE OF AUTO (K830741)United Surgical Corp.1983-08-11
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK (K831857)Medical Engineering Corp.1983-08-11
HR 100T (K831955)Thought Technology , Ltd.1983-08-11
CARDIVAN BLOOD PRESSURE MONITOR (K830682)Paramed Technology, Inc.1983-08-11
PENTAX FG-34JA GASTROFIBERSCOPE (K832007)Pentax Precision Instrument Corp.1983-08-11
EMIT SERUM TRICYCLIC ANTIDEPRESSENT (K831978)Syva Co.1983-08-11
SERALYZER MULTICOMPONENT CALIBRATORS (K832046)Miles Laboratories, Inc.1983-08-11
PISCES #3487 EPIDURAL LEAD FOR SPINAL (K831746)Medtronic Vascular1983-08-11
WAKO CPK TEST (K832004)Wako Chemicals USA, Inc.1983-08-11
MAGIC TM 125I T3 UPTAKE RADIOASSAY (K831613)Corning Medical & Scientific1983-08-11
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (K831961)Kent Laboratories, Inc.1983-08-11
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Every clearance here is in the API, with alerts when new ones post.