Atlas FDA

1984

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

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RecordFirmDate
HE TEST (K843843)Erich Jaeger, Inc.1984-12-04
MEDIPART FACE MASK & FILTER MP-30XM (K844493)Medipart Jerry Alexander1984-12-04
CAB2 COMPUTER ASSISTED BIOFEEDBACK (K843738)Discrete Data Systems, Inc.1984-12-04
WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT (K844196)Biological & Environmental Control Laboratories1984-12-04
TRACHEAL TUBE, REINFORCED, CUFFED (K844296)Sheridan Catheter Corp.1984-12-04
RESPIRATION & HEART RATE MONITOR 530 (K843681)Tri-Med, Inc.1984-12-04
OXYGEN CONCENTRATOR (K844328)Hospitak, Inc.1984-12-04
ELASTIC BANDAGE (K843056)Sterile Medical Systems1984-12-04
MEDIPART FILTER & TUBING MP-02X (K844491)Medipart Jerry Alexander1984-12-04
UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM (K843090)Geneva Laboratories, Inc.1984-12-04
MEDIPART FACE MASK MP-XM (K844494)Medipart Jerry Alexander1984-12-04
RESPIRONICS SLEEPEASY NASAL CPAP SYS (K843889)Respironics, Inc.1984-12-04
MEDIPART BACTERIA FILTER MP-30X (K844492)Medipart Jerry Alexander1984-12-04
BIOSELF TM 110 (K843699)Bioself, Inc.1984-12-04
ARM-A-FLOW INTRAVENOUS FLOW REGULATOR (K842209)Armour Pharmaceutical Co.1984-12-04
VENESECTION TRAY, ADULT 6050 (K843627)Pro-Lab, Inc.1984-12-04
MINUTEMAN CO2 MICROSURGICAL LASER OTO (K843514)American Surgical Laser, Inc.1984-12-04
SHAVE PREP KITS (K842989)Biological & Environmental Control Laboratories1984-12-04
TRANSLUX CL (K843823)Kulzer, Inc.1984-12-04
THYMATRON (K843923)Somatics, Inc.1984-12-03
ISOSTATIC CONDENSER (K843901)Shofu Dental Corp.1984-12-03
FLUOROSKAN (K842049)Flow Laboratories, Inc.1984-12-03
STARKET MODEL HMS (K844275)Starkey Laboratories, Inc.1984-12-03
OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE (K844326)Coe Laboratories, Inc.1984-12-03
TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 (K843355)Kontron Instruments, Inc.1984-12-03
SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS (K844349)Ivoclar USA, Inc.1984-12-03
CREDENT RADIOPAQUE CROWN & BRIDE (K842476)Credent Co.1984-12-03
DESERET INTRAVASCULAR CATHETER (K843033)Parke-Davis Co.1984-12-03
PULSE GENERATOR 689, 689B & 689L (K841225)Siemens Elema AB1984-12-03
RIONET HEARING AID HB-34AS (K844059)Rion Acoustic Instruments, Inc.1984-12-03
ACTIVE VERTICAL CORRECTOR ACTIVE BITE (K843344)Active Vertical Correctors, Inc.1984-12-03
PULSE GENERATOR 686, 686B 686L (K841230)Siemens Elema AB1984-12-03
ORAPIK PERIODONTAL SCALER (K844238)Dental Concepts, LLC1984-12-03
EASY EYES TM LENS CARRYING CASE (K841881)Eaton Medical Corp.1984-12-03
FILAFEX TM, ESTHETIC ORTHODONTIC WIRE (K843171)Berkley and Co.1984-12-03
TIGER BAND (K844324)World Wide Outdoor Marketing1984-12-03
C-22 PIT & FISSURE SEALANT (K844057)Pentron Corp.1984-12-03
DEL MAR AVIONICS 5509 NEURO-SCANNER (K841653)Del Mar Avionics1984-12-03
CREDENT RADIOPAQUE DENTURE RESIN (K842477)Credent Co.1984-12-03
TA-201 CLINICAL AUDIOMETER (K844069)Teledyne Avionics Div. of Teledyne1984-12-03
ENZYGNOST BETA-2 MICROGLOBULIN TEST (K843967)Behring Diagnostics, Inc.1984-12-03
PULSE GENERATOR 696, 696B & 696L (K841232)Siemens Elema AB1984-12-03
PLAYTEX BABY POWDER DEODORANT TAMPONS (K843551)Playtex, Inc.1984-12-03
HEARING AIDS 372 & 372 AI (K843068)Telex Communications, Inc.1984-12-03
AUDIOMETER (K843618)Grason-Stadler, Inc.1984-12-03
SURFLEX F (K844329)G-C Intl. Corp.1984-12-03
K-APATITE 20-40 MESH K-APATITE 40-60 (K843557)Katecho, Inc.1984-11-30
LKB 2230 ROTARY ONE (K843505)Lkb Instruments, Inc.1984-11-30
MICROTENS 7757 T.E.N.S. STIMULATOR (K844017)Rabar, Inc.1984-11-30
COUNT-A-PART PLUS (K841809)Diagnostic Technology, Inc.1984-11-30
HEPARIN CALIBRATOR ACA (K843202)E.I. Dupont DE Nemours & Co., Inc.1984-11-30
GAINOR MEDICAL SYRINGE (K844306)Gainor Medical1984-11-30
HEPARIN ACA ANALYTICAL TEST PACK (K843201)E.I. Dupont DE Nemours & Co., Inc.1984-11-30
GAINOR MEDICAL FLOWMAX NEEDLES (K844305)Gainor Medical1984-11-30
RESOLVE-CSF (K843122)Isolab, Inc.1984-11-30
LKB 2189 ULTROPROCESSOR (K843506)Lkb Instruments, Inc.1984-11-30
I.V. PUMP ADMINISTRATION SET (K843949)Travenol Laboratories, S.A.1984-11-30
TONGUE DEPRESSOR (K842461)The Torrent Corp.1984-11-30
CAPILLARY BLOOD COLLECTION TUBE (K843608)Medical Technomics, Ltd.1984-11-30
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN (K844079)Novametrix Medical Systems, Inc.1984-11-30
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (K844320)Belgium Surgical Co.1984-11-29
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (K843955)Extracorporeal Medical Specialities, Inc.1984-11-29
SURGEON'S GLOVES (K842884)Travenol Laboratories, S.A.1984-11-29
VISITEC MAGNIFYING SPECTACLES (K844038)Visitec Co.1984-11-29
Q-SCAN THERMOGRAPHY SYSTEM (K843124)Qmax Medical, Inc.1984-11-29
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN (K844406)Johnson & Johnson Professionals, Inc.1984-11-29
EVOKED POTENTIAL SYS (K842543)Bio-Logic Systems Corp.1984-11-29
BACTERIURIA DETECT DEVICE, MULTI SAMPLER (K843833)Applied Polytechnology, Inc.1984-11-29
AUTOFOCUS DUAL ELEMENT PROBE (K842777)Technicare Corp.1984-11-29
NUCLEOTOME (K844131)Medical Instrument Development Laboratories, Inc.1984-11-29
UNITED SKIN BARRIERS (K844046)Howmedica Corp.1984-11-29
COROMETRICS 115 FETAL MONITOR (K843385)Ge Medical Systems Information Technologies1984-11-29
EPHAR (K843214)Akron City Hospital1984-11-29
MULTILITH 2 PULSE GENERATOR 1141 & 2141 (K842220)Ela Medical, Inc.1984-11-29
3M LASER IMAGER (K843502)3M Company1984-11-29
POWER PACK 160 SIEMENS-ELEMA AB (K844590)Siemens Elema AB1984-11-29
IREX 730 MECHANICAL SECTOR SCANNER (K842408)Irex Corp.1984-11-29
HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI (K843637)Therapeutic Equipment Corp.1984-11-29
CYBEX TORSO TESTING & REHABILITATION (K843739)Cybex1984-11-29
BACTERIURIA DETECT. DEVICE APTEK II (K843834)Applied Polytechnology, Inc.1984-11-29
FIRM-A-TRON MARK X (K843583)Biotron , Ltd.1984-11-29
STONE, INSTRUMENT HONING (K844379)Treace Medical, Inc.1984-11-29
PRUITT IRRIGATION AND OCCLUSION CATHETER (K844094)Bionomy, Inc.1984-11-29
ZIMMER BONE CEMENT CENTRIFUGATION SYS (K843219)Zimmer, Inc.1984-11-29
WIREGUIDE OR GUIDEWIRE (K843012)Medi-Tech, Inc.1984-11-29
CASABLANCA (K841600)Arcon Corp.1984-11-29
MIXING CONTAINER (K843954)American Mcgaw1984-11-28
NUTRIBAG MIXING CONTAINER -2000 ML (K844410)Medical & Pharmaceutical Supplies, Inc.1984-11-28
DESERET SUBCLAVIAN JUGULAR CATHETER SET (K844113)Parke-Davis Co.1984-11-28
MODEL 800-A VERI/PPR (K840099)Verite1984-11-28
DERATA MEDI-JECTOR III (K844111)Derata Corp.1984-11-28
COLOR OPTIC CORNEAL EYE SHIELD (K843961)Colors IN Optics , Ltd.1984-11-28
CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 (K842754)Custom Ultrasonics1984-11-28
DESERET DENTRAL LINE CATHETER (K844219)Parke-Davis Co.1984-11-28
IOCARE PHACOEMULSIFICATION PACK (K843277)Chiron Vision Corp.1984-11-27
US 610 (K844036)Rich-Mar Corp.1984-11-27
TDX SALICYLATE (K844070)Abbott Laboratories1984-11-27
SCATAID (K842706)Sc Applied Technology, Inc.1984-11-27
ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT (K844167)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-27
RHINOMANOMETER A440 DIGITAL (K844230)Center Laboratories, Inc.1984-11-27
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Track 1984 automatically

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