Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CLEAR POROUS PLASTIC-HYPOALLERGENIC (K840948)Gainor Medical1984-08-14
RIONET HEARING AID HI-03 (K841935)Rion Acoustic Instruments, Inc.1984-08-14
IVAC KEOFEED HYDROPHILIC FEEDING TUBE (K842589)Y1984-08-14
ARTHROSCOPY KNIVES (K842820)Medtech Industries, Inc.1984-08-14
MIC GASTROSTOMY TUBE (K842076)Medical Innovations Corp.1984-08-14
VENTREZYME PHENOBARBITAL KIT IMMUNO (K842264)Ventrex Laboratories, Inc.1984-08-14
MINIM. ESSENTIAL MED. EAGLE M4144 W/ (K843044)Sigma Chemical Co.1984-08-14
TOYO JOZO URIC ACID TEST (K842103)Advocacy International, Ltd.1984-08-12
LACTALBUMIN HYDROLYSATE MED. CATALOG (K843045)Sigma Chemical Co.1984-08-12
ORTHO RESPIRATORY SYNCYTIAL VIRUS- (K841527)Ortho Diagnostic Systems, Inc.1984-08-12
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS (K842411)Sigma Chemical Co.1984-08-12
WRIGHT STAIN (K842744)E K Ind., Inc.1984-08-12
EMIT LOW & MEDIUM CALIBRATORS A (K842673)Syva Co.1984-08-12
NOVA BALLOON THERMODILUTION CATH. (K841639)Nova Medical Specialties1984-08-12
SOPHEIA/MP DIGITOXIN EIA KIT (K842578)Diagnostic Products Corp.1984-08-12
AST/GOT REAGENT SET UV RATE (K842521)Sterling Biochemical, Inc.1984-08-12
NEW METHYLENE BLUE N (K842743)E K Ind., Inc.1984-08-12
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL (K842656)Shaban Mfg. Co.1984-08-12
SIGMA 59-UV FOR ALANINE AMINOTRANSFER (K842564)Sigma Chemical Co.1984-08-12
FLUSH DEVICE (K833170)Transamerica Delaval, Inc.1984-08-12
IMMPULSE CORTISOL ASSAY REAGENTS (K842554)Aktis Corp.1984-08-12
NOVA BALLOON THERMODILUTION INFUSION (K841640)Nova Medical Specialties1984-08-12
PFLEX RESPIRATORY MUSCLE EXERCISER (K842634)Health Scan, Inc.1984-08-10
COMPUTER, CENTRAL PROCESSING UNIT (K841261)Nem Computer Corp.1984-08-10
ICP/6500 INDUCTIVELY-COUPLED PLASMA- (K842496)The Perkin-Elmer Corp.1984-08-10
ULTRA-VIOLET A SOURCE LIGHT EMITTING (K842575)Sola-Tan Intl.1984-08-10
SHILEY CARDIOTOMY RESERVOIR W/FILTER (K842711)Shiley, Inc.1984-08-10
SULFOSALICYLIC ACID, 3% W/V (K842915)E K Ind., Inc.1984-08-10
DMI ASPIRATOR 500 (K842204)Dean Medical Instruments, Inc.1984-08-10
SARNS EVACUPLEGE CATHETER (K842044)3M Health Care, Sarns1984-08-10
OPTIPHOR-10 (K842560)Gelman Sciences, Inc.1984-08-10
TISSUE INTEGRATED PROSTHESIS DRILL (K841813)Bofors Nobelpharma, Inc.1984-08-10
DCX-100 CHEST UNIT-GL-5000M (K841923)Transworld X-Ray Corp.1984-08-10
WRIGHT-GIEMSA QUICK STAIN (K842745)E K Ind., Inc.1984-08-10
OPTICLEAR (K842485)Gelman Sciences, Inc.1984-08-10
BATH TUB TRANSFER CHAIR (K842649)Guardian Products Co., Inc.1984-08-10
T.P.G. CAST TAPE (K842573)The Poly Group, Inc.1984-08-10
SCENTED MENSTRUAL PAD (K842764)Procter & Gamble Mfg. Co.1984-08-10
3M RAPIDSTAT LIGATING CLIP SYS (K842382)3M Company1984-08-10
ALPHACOIL (K842879)Japan Para Science Institute1984-08-10
PERIPHERAL DILATATION ANGIOPLASTY-CATH (K834429)American Edwards Laboratories1984-08-10
WALL GRAB BARS 98130-98136 (K842650)Guardian Products Co., Inc.1984-08-10
RADIOEAR M420H (K841933)Radioear Corp.1984-08-10
ADVANCED CARDIOVASCULAR BALLOON DILATA (K842556)Advanced Cardiovascular Systems, Inc.1984-08-10
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH (K842799)American Edwards Laboratories1984-08-10
HELENA COLOSCREEN SELF-TEST (K840903)Helena Laboratories1984-08-10
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH (K842798)American Edwards Laboratories1984-08-10
ESCHWEILER COMBI-ANALYSER MTA-500 (K840961)U.S. Science, Inc.1984-08-10
LEE BONE MARROW NEEDLES (K842106)Southland Instruments, Inc.1984-08-10
SDC SILICONE FORCEP SHODS PRODUCT (K842491)Science Development Corp.1984-08-10
SIMULTROPIN RADIOIMMUNOASSAY KIT LH (K842588)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-10
RESPIRONICS VENTEASY (K842693)Respironics, Inc.1984-08-10
UNSCENTED MENSTRUAL PAD (K842763)Procter & Gamble Mfg. Co.1984-08-10
GAMBRO PULSATILE MONITOR PLM 10-200 (K842503)Gambro, Inc.1984-08-10
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT (K842482)Amersham Corp.1984-08-10
GRAM IODINE (K842733)E K Ind., Inc.1984-08-10
TOYO JOZO G-GTP TEST (K842104)Advocacy International, Ltd.1984-08-10
ELECTRO-SAGE MODEL 203 (K842379)Weingart, Inc.1984-08-10
AMER. BIO-SCIENCE LAB T3 REAGENTS (K842590)American Bio-Science Laboratories1984-08-10
VENOUS CANNULA W/BENT, TIP WIRE (K842375)Dlp, Inc.1984-08-10
MULTIPRO CATHETER (K841797)Shiley, Inc.1984-08-10
R.L. MEDICAL TWIN LIGHT SOURCE (K842609)Tridak Division of Indicon, Inc.1984-08-09
SICKLE-HEME A/S HETEROZYGOUS CONTROL (K842955)Michclone Associates, Inc.1984-08-09
DOT-A, DOT-AR PXP-E, PXP-ER (K841905)Siemens Gammasonics, Inc.1984-08-09
RIDGEMATRIX 20/40 MESH, PERIOMATRIX (K842163)Orthomatrix, Inc.1984-08-09
MICROSTAT GAMMA COUNTER (K842902)Micromedic Systems1984-08-09
WESCOTT TYPE BIOPSY NEEDLE (K842406)Popper & Sons, Inc.1984-08-09
VAN-TEC OCCLUSION BALLOON CATHETER (K841941)Van-Tec, Inc.1984-08-08
CLINICOMP R.C.I. (K842540)Clinicomp, Inc.1984-08-08
LED STIMULATOR LS-05 (K834442)Teca, Inc.1984-08-08
ACCUSEAL LEG BAGS & EXTENSION TUBES (K842396)Convatec, A Division of E.R. Squibb & Sons1984-08-08
CORPAK URINARY DRAINAGE BAG (K842257)Corpak Co.1984-08-08
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT (K842384)Sola-Tan Intl.1984-08-08
KNEE-HIP MOBILIZER (K842881)Joint Mobilizer Systems, Inc.1984-08-08
ORTHO ACTIVE KNEE BRACE (K842790)Ortho Active Appliances , Ltd.1984-08-08
CAROLINA X-RAY CO. SIMPLAFLOAT TABLE (K842614)Carolina X-Ray Co., Inc.1984-08-08
URIHESIVE SYS MALE EXTERNAL CATHETER (K842397)Convatec, A Division of E.R. Squibb & Sons1984-08-08
G.I. CLEANSING KIT (K842130)Mmi, Inc.1984-08-08
SUR-FIT NIGHT DRAINAGE CONTAINER SET (K842395)Convatec, A Division of E.R. Squibb & Sons1984-08-08
AMPCO PROCEDURE TRAYS / PACKS (K843114)Associated Medical Products Co.1984-08-08
ORTHO ACTIVE WRIST BRACE (K842791)Ortho Active Appliances , Ltd.1984-08-08
ANKLE MOBILIZER (K842882)Joint Mobilizer Systems, Inc.1984-08-08
COOPER LASERSONICS, 8000 ND.YAGLASER (K841869)Cooper Lasersonics, Inc.1984-08-08
LIFEMED LIFECOIL CATHETERS (K841929)Lifemed of California1984-08-08
BIOLAS YAG 100 (K842670)Advanced Biomedical Instruments1984-08-08
HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS (K841295)Bow/Parm1984-08-08
MENTOR 150 PLUS TRANSCUTANEOUS ELEC. (K842812)Mentor Corp.1984-08-08
EMG MODULE, EMG1, W/OPTIONAL SPEAKER (K842124)Endotek Corp.1984-08-08
VACCESS FEMORAL CANNULA (K842864)Vas-Cath of Canada , Ltd.1984-08-08
SERUM IRON & SERUM IRON BINDING CAPACI (K842155)Diagnostic Chemicals, Ltd. (Usa)1984-08-07
TDX REA IRON DIAGNOSTIC KIT (K842505)Abbott Laboratories1984-08-07
DHEA-S DIRECT RIA KIT (K842555)Biotecx Laboratories, Inc.1984-08-07
LUDLUM 88 DOSE CALIBRATOR (K842570)Ludlum Measurements, Inc.1984-08-07
ORNITHINE INDOLE MOTILITY (K842851)Anarobe Systems1984-08-07
SERUM IRON & SERUM IRON BINDING CAPACITY (K842156)Diagnostic Chemicals, Ltd. (Usa)1984-08-07
COMMODE CHAIR 98200 (K842651)Guardian Products Co., Inc.1984-08-07
RENEAU UNIT (K840841)Reneau, Inc.1984-08-07
VMT GENTLE-HALER (K842988)Vortran Medical Technology 1, Inc.1984-08-07
AMERICAN MEDICAL OPTICS PHOTOKERATO (K842128)American Medical Optics1984-08-07
HIPPURATE TEST REAGENT (K842871)Irvine Diagnostic Services1984-08-07
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Track 1984 automatically

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