Atlas FDA

1983

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

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RecordFirmDate
SILICONE RUBBER ISOLATION SLEEVE 351-01 (K833198)Intermedics, Inc.1983-10-27
ACCU-PREP PROGRAMMABLE AUTO-DILUTER (K832809)Beckman Instruments, Inc.1983-10-27
SIMMONS CITRATE AGAR (K833201)Acumedia Manufacturers, Inc.1983-10-27
LACTOSE (K833210)Acumedia Manufacturers, Inc.1983-10-27
YEAST BEEF AGAR-ANTIBIOTIC MED.4 (K833218)Acumedia Manufacturers, Inc.1983-10-27
APLICARE ALCOHOL PREP PAD (K833182)Aplicare, Inc.1983-10-27
DEXTROSE (K833214)Acumedia Manufacturers, Inc.1983-10-27
YERSINIA SELECTIVE AGAR (K833205)Acumedia Manufacturers, Inc.1983-10-27
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM (K831825)Hospitak, Inc.1983-10-27
DISPOSBLADE LARYNGOSCOPE (K833133)Geller & Bozeman1983-10-27
AK AGAR 2 (K833207)Acumedia Manufacturers, Inc.1983-10-27
WLECTROCARDIOGRAPH ECG-7204 (K831274)Nihon Kohden America, Inc.1983-10-27
STANDARD METHOD BROTH (K833217)Acumedia Manufacturers, Inc.1983-10-27
DEOXYCHOLATE LACTOSE AGAR (K833203)Acumedia Manufacturers, Inc.1983-10-27
MOELLER DECARBOXYLASE BROTH (K833202)Acumedia Manufacturers, Inc.1983-10-27
MR-VP BROTH (K833208)Acumedia Manufacturers, Inc.1983-10-27
LOWENSTEIN-JENSEN MEDIUM BASE (K833220)Acumedia Manufacturers, Inc.1983-10-27
CLOSTRIDIUM DIFFICILE (K833136)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-10-27
CS-11 (K832500)Chema-Scutum, Inc.1983-10-27
BEEF EXTRACT (K833215)Acumedia Manufacturers, Inc.1983-10-27
TECH AGAR (K833206)Acumedia Manufacturers, Inc.1983-10-27
PACEMAKER PROGRAMMER #2032 (K831859)Vitatron Medical BV1983-10-27
L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 (K833164)Sigma Chemical Co.1983-10-27
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/ (K832026)Litton Medical Electronics1983-10-26
SERVOMED STANDARD SMS 104 (K832041)Litton Medical Electronics1983-10-26
LME HEART-RATE MONITOR (K832016)Litton Medical Electronics1983-10-26
SERVOMED BASIC BEDSIDE UNIT - VARIOUS (K832024)Litton Medical Electronics1983-10-26
MGI STRENGTH/FITNESS SYS-MODEL #PU-101 (K832528)Mgi Strength/Fitness Systems, Inc.1983-10-20
BLOOD OXYGENATOR 5070 (K831894)Shiley, Inc.1983-10-20
HYPOTHERMIC MYCARDIAL PROTECTION DEV (K832417)3M Health Care, Sarns1983-10-20
ULTRA LIGHT RAAF CATHETER (K832784)Quinton, Inc.1983-10-20
OXFORD MARK 2 EXTERNAL FIXATOR (K833114)Johnson & Johnson Professionals, Inc.1983-10-20
PLASTIC SUCTION TIPS (K832521)Wells Johnson Co.1983-10-20
ASPIRATOR (K832274)Wells Johnson Co.1983-10-20
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A (K831458)Electromedics, Inc.1983-10-20
ATAC 4700 HEMATOLOGY CELL COUNTER (K832116)Turpen Laboratory Systems, Inc.1983-10-20
INTRAMEDULLARY BONE PLUG (K832328)Kirschner Medical Corp.1983-10-20
SURGIKEK PENILE PROSTHESIS TAIL EXTEND (K832043)Medical Engineering Corp.1983-10-20
PHYSIOLOGICAL PRESSURE MEASUREMENT CATH (K832604)Camino Laboratories, Inc.1983-10-20
AUTOMATIC ENDOSCOPE (K832458)American Endoscopy, Inc.1983-10-20
MULTIPOLAR TEMPORARY CARDIAC (K831804)Oscor, Inc.1983-10-20
HOLTA-MED RECORDER (K832395)Holta-Med1983-10-20
LEAD INTRODUCER SETS-EB-S8 & EB-S12 (K831751)Oscor, Inc.1983-10-20
PORTABLE LIFECARE VENTILATOR PLV-100 (K832467)Lifecare Services, Inc.1983-10-20
TEMP. CARDIAC PACING WIRE TME 60/61/65 (K831695)Oscor, Inc.1983-10-20
PERMANTHANE #866 BIPOLAR COAXIAL (K832987)Pacesetter Systems1983-10-20
TRI-COUNT 7 (K833130)Hematology Marketing Assoc.1983-10-20
SUCTION TIPS (K832520)Wells Johnson Co.1983-10-20
PURGES LINES, PL-45 & PL-33 (K833048)American Bentley1983-10-20
IMPLANTABLE ENDOCARDIAL PACING LEADS (K831997)Oscor, Inc.1983-10-20
PHYSIOLOGICAL PRESS. MEASUREMENT CATH (K832579)Camino Laboratories, Inc.1983-10-20
PLATELET AGGREGATION REAGENT SET (K832428)Helena Laboratories1983-10-20
USCI ANGIOGRAPHIC BALLOON CATHETER (K831854)C.R. Bard, Inc.1983-10-20
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH (K833106)Biotronik Sales, Inc.1983-10-20
BIOTRONIK N, BIPOLAR PEB-60/4-N (K833099)Biotronik Sales, Inc.1983-10-20
FIXATION STAPLE DRIVER/EXTRACTOR (K832884)Warsaw Orthopedic, Inc.1983-10-20
SILICONE-SILVER PENILE PROSTHESIS-ESK (K830667)Dacomed Corp.1983-10-20
ASPIRATING TUBING (K832519)Wells Johnson Co.1983-10-20
BLOOD OXYGENATOR 50 70/S (K831895)Shiley, Inc.1983-10-19
SURGICAL STOCKINGS (K832273)Wells Johnson Co.1983-10-19
SATELEC SUPRASSON SP 3055 (K832665)Spelna, Inc.1983-10-19
QUANTAPHASE B-12-COBALMIN-FOLATE- (K833247)Bio-Rad1983-10-19
PERCLUDER DL OCCLUDING BALLOON (K832386)Datascope Corp.1983-10-19
PERCUTANEOUS NEPHROSTOMY CATHETER (K833008)Medical Engineering Corp.1983-10-19
IONESCU-SHILEY LOW POROSITY COMPOSITE (K831865)Shiley, Inc.1983-10-19
HARD CONTACT LENS CASE (K831973)Moonbeam International, Inc.1983-10-19
GASTRIC SUMP TUBES (K833054)Medovations, Inc.1983-10-19
CATAREX DIAP. EXTRACAPSULAR CATARACT (K832446)Calliope Corp.1983-10-19
VXTRA OCUTOME KIT (K832980)Vxtra Corp.1983-10-19
HEMACOMP 7 OR HEMATIL 7 (K832890)Texas Intl. Laboratories, Inc.1983-10-19
BIOTRONIK DN UNIPOLAR PE-60/4-DN & (K833098)Biotronik Sales, Inc.1983-10-19
ELECATH PACEWEDGE DUAL PRESS. BIPOLAR (K832850)Electro-Catheter Corp.1983-10-19
OCUTOME PARATUBING SET (K832938)Vxtra Corp.1983-10-19
BIOTRONIK D2K UNIPOLAR PE-60/4 (K833104)Biotronik Sales, Inc.1983-10-19
KARICKHOFF FLYING CORPUSCLE VIEWER (K831829)Surgidev Corp.1983-10-19
VIDEO-DILUTION TECH. MARK I INSTRUMENT (K831057)Angio Tec Corp.1983-10-19
ACCU-SPHYG (K832060)Olympic Medical Corp.1983-10-19
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC (K833101)Biotronik Sales, Inc.1983-10-19
AIR FLUID EXCHANGE PUMP (K832761)Intek Int'L, Inc.1983-10-19
BABY LIGHT DOSIMETER (K832298)Rocky Mountain Medical Corp.1983-10-19
TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO (K831245)Ritter Co.1983-10-19
CODY SACCULOTOMY TACK (K832068)Micromedics, Inc.1983-10-19
NOVA BALLOON THERMODILUTION INFUSION (K832287)Nova Medical Specialties1983-10-19
SATELEC PROPHY UNIT PU-2000 (K832673)Spelna, Inc.1983-10-19
PATIENT MONITOR 788 33A (K831943)Hewlett-Packard Co.1983-10-19
BIOTRONIK I-UNIPOLAR PE-60/2-13 (K833108)Biotronik Sales, Inc.1983-10-19
EAGLE 2000 STERILIZER SERIES GAS/AERA (K832945)Amsco Co.1983-10-19
SCIENTRONICS 10K EYE MAGNET (K832950)Scientific Manufacturer1983-10-19
IONESCU-SHILEY LOW POROSITY AORTIC GRAFT (K831880)Shiley, Inc.1983-10-19
PEDIATRIC ILLUMINATING URETERAL (K832807)Van-Tec, Inc.1983-10-19
TOP THREE WAY STOPCOCK (K832625)Top Surgical Manufacturers Co.1983-10-19
AXIOM PERFUSSION CANNULA (K832475)Axiom Medical, Inc.1983-10-19
CURAY-SUPPORT, CORE BUILD-UP MATERIAL (K832781)Scientific Pharmaceuticals, Inc.1983-10-19
PATIENT MONITOR #78832A (K831944)Hewlett-Packard Co.1983-10-19
DEFLECTING GUIDE WIRE (K833242)Van-Tec, Inc.1983-10-19
TEMP. REPAIR KIT-DUAL LUMEN CATHETER (K831587)Norton Performance Plastics Corp.1983-10-19
EPCOR MULTIELECTRODE TEMP. PERVENOUS (K832561)Cordis Corp.1983-10-19
LUNG POWER (K832195)Consolidated Medical Technologies1983-10-18
URETERAL DILATION SET (K832808)Van-Tec, Inc.1983-10-14
FLOW-PAC SHOLESTEROL REAGENT SET (K832780)American Research Products Co.1983-10-14
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Track 1983 automatically

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