Atlas FDA

1983

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

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RecordFirmDate
DENTIN BONDING AGENT (K833473)Johnson & Johnson Professionals, Inc.1983-12-27
X-BEAM FILM 3TC (K833592)Amorient Ent.1983-12-27
DUOFLO 6F (K833303)Argon Medical Corp.1983-12-27
ANGIO-SET INTRAVENOUS CATH. SET (K833657)Deseret Medical, Inc.1983-12-27
ACE/KYLE SELF TAPPING CANNULATED TITA (K833866)Buckman Co., Inc.1983-12-27
EBV-VCA-IGM IFA TEST SYSTEM (K833014)Zeus Scientific, Inc.1983-12-27
COMFEEL BARRIER CREAM (K833569)Coloplast A/S1983-12-27
PERITONEAL CATHETER-CHANGES- (K833749)Quinton, Inc.1983-12-27
PULSATOR ARTERIAL BLOOD SAMPLING SYRIN (K833582)Concord Laboratories, Inc.1983-12-27
BRONCHOSCOPY TUBE W/ULTRA LOCUFF (K833297)Surgitek1983-12-27
KELLY CHOLANGIOCATH (K833920)Perry, Div.1983-12-27
SF BROTH (K834013)Micro Media Laboratories1983-12-27
INTERSEPT 40 MICRON FILTER (K833477)Extracorporeal Medical Specialities, Inc.1983-12-27
ELECTRO-MYOSCOPE 85 (K833927)Biomedical Design Instruments1983-12-27
TEMPTREND II (K833904)Biosynergy, Inc.1983-12-27
VALPROIC ACID ANALYTICAL TEST PACK (K833381)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
MALE THERAPEUTIC POTENT AID (K832543)Mace'S Scientific1983-12-27
NON - ADHERENT BANDAGE (K833733)American Medical Disposable, Inc.1983-12-27
A3B (K834065)Remel Co.1983-12-27
ARTHROSCOPIC LEG HOLDER 434-21 (K834076)Custom Medical Products, Ltd.1983-12-27
VALPROIC ACID CALIBRATOR (K833382)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
GOLD SEADS (K834027)Radiation Safety & Nuclear Products, Inc.1983-12-27
TUCK-TITE COLON FLUID RETAINER (K833860)Clayton Medical Products, Inc.1983-12-27
LEAP STREP TEST KIT (K833738)Cooper Biomedical, Inc.1983-12-27
PROCAINAMIDE ANALYTICAL TEST PACK (K833384)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
BDH UNIVERSAL HIP SYSTEM SURGEON (K833468)Carbomedics, Inc.1983-12-27
VENOSET MULTI-MED PIGGYBACK W/IVEX-2 (K833740)Abbott Laboratories1983-12-27
CHEM KIT THEOPHYLLINE DIAG. KIT (K833683)Abbott Laboratories1983-12-27
HS4 HEAD/NECK FEMORAL PROSTHESES (K833461)Osteonics Corp.1983-12-27
CURITY 100% SILICONE COUDE' CATHETER (K833790)The Kendal Co.1983-12-27
EMIT NETILMICIN ASSAY (K833715)Syva Co.1983-12-27
SILICONE RUGGER DISPOSABLE YOKE-CPAP (K834078)Vesta, Inc.1983-12-27
OPEN END SPRING GUIDE (K832607)C.R. Bard, Inc.1983-12-27
PERI-GUARD PERICARDIAL PATCH-HERNIA (K833021)Genetic1983-12-26
OLBERT CATHETER SYSTEM (K833616)Meadox Medicals, Div. Boston Scientific Corp.1983-12-26
DEGUPLUS 2 (K833445)Degussa Dental, Inc.1983-12-26
SUPRA AP CHOICE 83 (K833280)Genesis Industries, Inc.1983-12-26
IMPRESSION TUBE ADJUSTABLE (K833485)Zefr, Inc.1983-12-26
COSMODYN-S INTERFERENTIAL MUSCLE STIM (K833945)Leo Unlimited, Inc.1983-12-23
DUCKBILL VOICE PROSTHESIS & TRACHEO (K832967)American V. Mueller1983-12-23
BIONICARE STIMULATOR BIO-1 (K832805)Murray Electronics1983-12-23
GALANTE FIBER METAL TOTAL HIP (K833912)Zimmer, Inc.1983-12-22
SELENITE BROTH (K834015)Micro Media Laboratories1983-12-22
LOW PROFILE STEERABLE-INTRAOPERATIVE (K833248)Advanced Cardiovascular Systems, Inc.1983-12-22
ACTIMETER UB-103 (K832724)Copal, Inc.1983-12-22
BIGGY AGAR NICKERSON MEDIUM (K834019)Micro Media Laboratories1983-12-22
PERI MIRROR/SALIVA EJECTOR (K833429)Dentec, Inc.1983-12-22
RATEMINDER II SPECIALTY CARE (K833520)Anatros Corp.1983-12-22
NARCOTRACE 80 (K830338)Narco Scientific1983-12-22
PRE-GELLED DISPOS ELECTRODE (K832877)Advance Tech Intl.1983-12-22
OXY MONITOR 5-RANGE DUAL-THERMISTOR (K832652)Litton Medical Electronics1983-12-22
CHOCOLATE AGAR W/CHEMICALLY DEFINED (K834017)Micro Media Laboratories1983-12-22
BACTROL TB SLIDE (K833900)Difco Laboratories, Inc.1983-12-22
KNEE PROSTHESIS-PATELLA COMPONENT (K833411)Johnson & Johnson Professionals, Inc.1983-12-22
API STAPHASE III (K833988)Analytical Products, Inc.1983-12-22
BIOMET BIPOLAR PROSTHESIS (K833175)Biomet, Inc.1983-12-22
IRI SPEC URINALYSIS CONTROL (K832713)Intl. Remote Imaging Systems1983-12-22
STERILE RUBBER BANDS (K834063)Devon Industries, Inc.1983-12-22
MOTILITY INDOLE ORNITHINE-MEDIUM (K834003)Micro Media Laboratories1983-12-22
SIMMONS CITRATE AGAR (K834009)Micro Media Laboratories1983-12-22
AMEDA NEONATAL RESUSCITATION UNIT- (K832637)Egnell, Inc.1983-12-22
TRANSCUTANEOUS ELECTRONIC NERVE STIMU (K831938)Joseph M. Piocentile1983-12-22
STEDIFLO INFUSION SET (K832739)Dravon Medical, Inc.1983-12-22
MICROPROCESSOR VENTILATOR 7200 (K833786)Puritan Bennett Corp.1983-12-22
GN BROTH (K834016)Micro Media Laboratories1983-12-22
VENOSET MULTI MED DUAL RATE PIGGYBACK (K833741)Abbott Laboratories1983-12-22
POTATO DEXTROSE AGAR (K834014)Micro Media Laboratories1983-12-22
MONITORING SYSTEM AS100-AS115 RECORD (K832754)Air-Shields, Inc.1983-12-22
EPOS CHEMISTRY ANALYZER 5060 & 6410 (K833448)Emd Chemicals, Inc.1983-12-22
KLIGLER IRON AGAR (K834001)Micro Media Laboratories1983-12-22
RX IV PENTRON IV (K833285)Genesis Industries, Inc.1983-12-22
ACLAIM-QAP IBM PERSONAL COMPUTER EDT (K833353)American Dade1983-12-22
CYSTINE TRYPTIC MEDIUM (K834007)Micro Media Laboratories1983-12-22
ACUTE HEMODIALYSIS TRAYS (K833139)Intermed, Inc.1983-12-22
EMIT & METHOFREXATE ASSAY (K833634)Syva Co.1983-12-22
HEMASTICK 1-1.5 & 2-DISPOS. BLOOD (K833816)Medprobe Laboratories1983-12-22
LYSINE IRON AGAR (K834002)Micro Media Laboratories1983-12-22
KLEIN WIRE TIGHTENER/BIONIC WIRE (K833726)Bionic Instrument Corp.1983-12-22
MYCOBIOTIC AGAR (K834004)Micro Media Laboratories1983-12-22
SIM MEDIUM (K834012)Micro Media Laboratories1983-12-22
CAMPY MEDIUM (K834018)Micro Media Laboratories1983-12-22
EMERGENCY ASPIRATOR (K833785)Vitalograph , Ltd.1983-12-22
VASCUTEK VASCULAR PROTHESIS VP1200K/50K (K830016)Pacesetter Systems1983-12-21
MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000 (K833480)Cooper Lasersonics, Inc.1983-12-21
MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM (K834092)Rehab Medical Specialties, Inc.1983-12-20
C & B57 PENTRON C & B57 (K833288)Genesis Industries, Inc.1983-12-20
RIANEN LUTEINIZING HORMONE RIA KIT (K833376)New England Nuclear1983-12-20
HEARING AID (K833926)Rion Acoustic Instruments, Inc.1983-12-19
PDM SILOXANE PROSTHETIC ORBIT (K832151)Delaware Prosthetics, Inc.1983-12-19
CLOSTRIDIUM DIFFICILE EY AGAR P2787 (K833760)Gibco Laboratories Life Technologies, Inc.1983-12-16
TUBING CONNECTORS EC-2XXX SERIES (K833322)Gish Biomedical, Inc.1983-12-16
CD-102 CARBON DIOXIDE ANALYZER/RECOR (K833739)Instrumentarium Corp.1983-12-16
WILLIAM HARVEY H-71-5-F CARDIOTOMY (K833479)C.R. Bard, Inc.1983-12-16
AQUAPAK 020 HUMIDIFIER ADAPTER (K833974)Respiratory Care, Inc.1983-12-16
CARIEL F12 (K823934)Odam1983-12-16
RESPIRONICS RESCUE DOME (K833328)Respironics, Inc.1983-12-16
8 FRENCH DILATOR 15CM, W/LUER LOCK (K833965)Quinton, Inc.1983-12-16
BATTERY-OPERATED ELECTROCARDIOGRAPH (K832421)Somatronix Research Corp.1983-12-16
MAGNATRODE CARDIAC MONITORING ELECTRODE (K832516)R2 Corp.1983-12-16
FACTOR II DEFICIENT SUBSTRATE PLASMA (K834031)Helena Laboratories1983-12-16
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Every clearance here is in the API, with alerts when new ones post.