Atlas FDA

1979

2,434 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CHRONAEROBIC (CA-1) (K792122)Stanford Scientific, Inc.1979-11-27
CORDIA RF (K792061)Cordis Corp.1979-11-27
HARLECO BRAND CLINICARD LIPASE TEST SET (K791922)Dade, Baxter Travenol Diagnostics, Inc.1979-11-27
SCI-PHARM POLIFIL ANTERIOR RESTORATIVE (K791602)Scientific Pharmaceuticals, Inc.1979-11-27
SERIES S (BEHIND-THE-EAR-HEARING AID) (K792198)Maico Hearing Instruments, Inc.1979-11-27
SHILEY PRESSURE RELIEF ADAPTER PRA (K792265)Shiley, Inc.1979-11-27
UNIFOCAL 2-UNIPOLAR & BIPOLAR (K792199)American Pacemaker Corp.1979-11-27
A.D.E. ASPEN DISPERSIVE ELECTRODE (K792315)Zimmer, Inc.1979-11-27
ANTI-HUMAN IGG SERUM (K791281)Diagnostica, Inc.1979-11-27
VDC (K791756)Life Sciences Manufacturing, Inc.1979-11-27
AIR INCENTIVE SPIROMETER, W/NEBULIZER (K792217)Airlife, Inc.1979-11-27
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT (K792188)Abbott Laboratories1979-11-27
MW-8000 (K792304)Midwest1979-11-27
CO 2 METER (K792155)Boehringer Laboratories1979-11-27
FISCH DRILL SYSTEM (K792159)Jedmed Instrument Co.1979-11-27
DURAZYME GOT/AST (K792208)American Monitor Corp.1979-11-27
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES (K792234)Boehringer Mannheim Corp.1979-11-27
LS-100 (K792302)Midwest1979-11-27
CIRCAPAK (K792268)Respiratory Care, Inc.1979-11-27
ANTI-HUMAN KAPPA SERUM (K791284)Diagnostica, Inc.1979-11-27
USHER'S MARLEX TUBULAR MESH (K792281)Davol, Inc.1979-11-27
1 STEP (K792003)Betta Dental, Inc.1979-11-27
OMNICOR PROGRAMMER MODEL 222C (K791419)Cordis Corp.1979-11-27
UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR (K792232)American Pacemaker Corp.1979-11-27
MODEL TM2-BEHIND-THE-EAR TINNITUS (K792214)Starkey Laboratories, Inc.1979-11-27
UNIFOCAL 1 UNIPOLAR DEMAND R WAVE (K791955)American Pacemaker Corp.1979-11-27
MISTY BEBULIZER (K792218)Airlife, Inc.1979-11-27
MODEL CF-300 THREE CHANNEL FLOW METER (K792190)Wilton Webster Laboratories1979-11-21
MEDTRONIC BURR HOLE PLUG & CAP (K792206)Medtronic Vascular1979-11-21
ROCHE SENSOR ADAPTOR (K791559)Roche Medical Electronics, Inc.1979-11-21
MEDTRONIC MODEL 7728 NEUROMOD (K792311)Medtronic Vascular1979-11-21
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON (K792283)Arzbaecher & Co.1979-11-21
SARNS MEDIASTINAL AND PERICARDIAL TUBE (K792070)3M Health Care, Sarns1979-11-21
MEDTRONIC MODEL 9408 TELETRACE TRANSMIT (K792246)Medtronic Vascular1979-11-21
HEART RATE MONITOR MD-1 (K792312)Medical Devices, Inc.1979-11-21
ELECTROCARDIOGRAPH, MODEL ECG-5151 (K792229)Nihon Kohden America, Inc.1979-11-21
GDC 802-DEVELOPMENT NAME (K792210)Deringer-Ney, Inc.1979-11-20
HISTO-CENTER II (K792095)Thermolyne Corp.1979-11-20
POROUS ELASTIC RUBBER BANDAGE (K792065)Norman R. Sanborn Co.1979-11-20
TROCAR CATHETER/THORACIC CATHETER (K792202)Portex, Inc.1979-11-20
FOLLICLE STIMULATING HORMONE (FSH) KIT (K792063)Cis Radiopharmaceuticals, Inc.1979-11-20
I.V. STRIP (K792049)E-Med Corp.1979-11-20
COUITER/CMS ISOTONIC BLOOD BANK SALINE (K792101)Coulter Electronics, Inc.1979-11-20
HYDROGEL-PREP (K791726)Spenco Medical Corp.1979-11-20
VISALENS CONCENTRATED CLEANER CONT LENS (K791524)Pfizer, Inc.1979-11-20
HOWMEDICA A-35 DENTAL ALLOY (K791973)Howmedica Corp.1979-11-20
ORALUMINATOR III AUTO-LIGHT (K791771)Midwest1979-11-20
VITA-STAT MODEL 900-D (K792193)Vita-Stat Medical Services, Inc.1979-11-20
VITA-STAT MODEL 900-S (K792194)Vita-Stat Medical Services, Inc.1979-11-20
HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY (K792008)Howmedica Corp.1979-11-20
HYDRON BURN DRESSING FIELD KIT (K791865)National Patent Development Corp.1979-11-16
3M MICROBIAL PROFILE SYSTEM GRAM (K791789)3M Company1979-11-16
CYLER/HEATER FOR PERITONEAL DIALYSIS (K791584)American Medical Products, Inc.1979-11-16
SPECIMAN CUP & EMESIS BASIN (K792211)General Clinical Plastics Corp.1979-11-16
LIO-714 OPACITYMETER (K790526)Laser Industries , Ltd.1979-11-16
MEMCO 300 FILM CHANGER (K792068)Memco, Inc.1979-11-16
MODEL DM 353 & DM-353-L SINGLE NEEDLE (K792174)Extracorporeal Medical Specialities, Inc.1979-11-16
HAAG-STREIT SLIT LAMP 900 (K792083)Lumenis, Inc.1979-11-16
HYPO-ALLERGENIC CLOTH ADHESIVE TAPE (K792102)National Patent Development Corp.1979-11-16
HYPO-ALLERGENIC PAPER ADHESIVE TAPE (K792103)National Patent Development Corp.1979-11-16
CONPHAR LATEX FOLEY CATH-STERILE (K792109)Conphar, Inc.1979-11-16
2 FR KELMAN CHAMBER MAINTAINER (K792096)Heyer Schulte Corp.1979-11-16
RING-ORIFICE, TURBULENT FLOW PNEUMOT (K791730)Research Development Corp.1979-11-16
CONPHAR SILICONE COATED FOLEY CATH (K792111)Conphar, Inc.1979-11-16
DEODORANT CAREFREE PANTY SHIELDS (K792195)Personal Products Co.1979-11-16
3M BRAND TOTAL LEG COMPRESSION TLC SYS. (K791894)3M Company1979-11-16
CONPHAR 100% SILICONE FOLEY CATH-STER. (K792107)Conphar, Inc.1979-11-16
MEVATRON 74X MEDICAL LINEAR ACCELERATOR (K791967)Siemens Medical Laboratories, Inc.1979-11-16
CLOSED SYSTEM FOLEY CATHERIZATION PROCED (K791598)Walpak Co.1979-11-16
SAFE RETURN COT. #9675 & CONNECTOR ADAPT (K792044)Concept, Inc.1979-11-16
TC02M PRECISION GAS CALIBRATOR (K792011)Novametrix Medical Systems, Inc.1979-11-16
ADR-10600(ADR 400),10601 (ADR 300) (K791342)Physio-Control Corp.1979-11-16
HYGENIC RUBBER DAM LUBRICANT (K791970)The Hygenic Corp.1979-11-16
FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT (K792056)Fisher Scientific Co., LLC1979-11-16
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY (K792033)Medline Industries, Inc.1979-11-16
3388 REPORTING INTEGRATOR (K792158)Hewlett-Packard Co.1979-11-16
BARNES-HIND WETTING & SOAKING SOLUTION (K791901)Barnes-Hind, Inc.1979-11-16
DISPOSABLE PERITONEAL DIALYSIS EXTENSION (K791722)American Medical Products, Inc.1979-11-16
ROTAZYME (K791746)Abbott Laboratories1979-11-16
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS (K791948)Intl. Diagnostic Technology1979-11-16
MODELS DM-360 & DM-350-L SINGLE PATIENT (K792173)Extracorporeal Medical Specialities, Inc.1979-11-16
AEROBITRON II (K792120)Stanford Scientific, Inc.1979-11-15
AEROBITRON III (K792121)Stanford Scientific, Inc.1979-11-15
MEDTRONIC MODELS 5984/5985 (K791316)Medtronic Vascular1979-11-15
BIOBRANE BRAND TEMPORARY WOUND DRESSING (K791184)Hall-Woodroof, Inc.1979-11-15
ADJUSTABLE TUBE TREE FOR ANESTH. HOSES (K792148)Medical Innovations Corp.1979-11-15
CARDIO CK-B RIA KIT (K791582)Nuclear Medical Systems, Inc.1979-11-15
3M HS 22 FEMORAL COMPONENT (K792181)3M Company1979-11-15
ICE CONTAINER I.C.E. (K792182)Delta Medical Industries1979-11-15
PAP RIA KIT (K791735)Nuclear Medical Systems, Inc.1979-11-15
MILLAR MIKRO-TIP CATHETER TRANSDUCER (K792177)Millar Instruments, Inc.1979-11-15
SHILEY CARDIOPLEGIC SOLUTION DEL SETS (K791947)Shiley, Inc.1979-11-13
TEMPORARY TRANSVENOUS PACMKER. ELECTRODE (K792131)Stanco Medical, Inc.1979-11-13
8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO (K792196)Photovolt Corp.1979-11-13
POPE UMBRELLA TUBE (K791680)Xomed, Inc.1979-11-13
NON-A-THERM (K792037)Labarge, Inc.1979-11-13
ATMOS ENT PATIENT CHAIR #5 (K791938)Jedmed Instrument Co.1979-11-13
TECHNICON FAST-LC SYS. ANTICONVU DRUGS (K791979)Technicon Instruments Corp.1979-11-13
TRANSVENOUS BALLOON CATH. INTRO. KIT (K792130)Stanco Medical, Inc.1979-11-13
RIANEN, VITAMIN B12 ASSAY SYSTEM (K792175)New England Nuclear1979-11-13
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Every clearance here is in the API, with alerts when new ones post.