Atlas FDA

1980

2,857 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COMPUTRIM 900 (K800939)Amf, Inc.1980-05-28
ENDOCARD. PACING LEAD STD. LENGTH PL202 (K800350)Daig Corp.1980-05-28
ASL CUSTOM IN-THE-EAR HEARING AID #L (K801023)American Sound Labs1980-05-28
ENDOCARD. PACING LEAD LONG LENGTH PL200 (K800349)Diag Corp.1980-05-28
CHOCOLATE AGAR W/ENRICHMENTS (K800981)Quality Assurance Laboratory, Inc.1980-05-28
TELESONIC, SOUNDEX & GENERIC V-101 (K801066)Telesonic, Inc.1980-05-28
FIBER OPTIC LIGHT SOURCE (K801176)Aspen Laboratories, Inc.1980-05-28
TELESONIC, GENERIC & SOUNDEX C-102 (K801067)Telesonic, Inc.1980-05-28
PACEMAKER, ELECTRODE, PERM. & TEMP. (K800351)Daig Corp.1980-05-28
OTICON EARETTE HEARING AID #E17CF (K801003)Oticon Corp.1980-05-28
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (K800672)Diagnostic Solutions, Inc.1980-05-28
REAGENTS FOR DETERM. TOTAL BILIRUBIN (K800675)Diagnostic Solutions, Inc.1980-05-28
ANALOR FOUR-DENTAL MODEL (K801100)Narco Mckesson Co.1980-05-28
REAGENT FOR DETERM. CREATINE PHOSPHOKINA (K800684)Diagnostic Solutions, Inc.1980-05-28
REAGENTS FOR DETERM. SODIUM IN HUMAN SUM (K800676)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. INORGANIC/PHOSPHORUS (K800690)Diagnostic Solutions, Inc.1980-05-28
CLINICAL DATA SYSTEM (CAM) MODULE (K801029)Adac Laboratories1980-05-28
REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM (K800683)Diagnostic Solutions, Inc.1980-05-28
ANGIO-FLO MONITORING KIT (K801173)Hospital Products Co.1980-05-28
ILLUMINATED SPECULUM (K801058)Designs For Vision, Inc.1980-05-28
CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA (K801037)Union Carbide Corp.1980-05-28
UNIPOLAR LEAD CONFIGURATION CONDUCTOR (K800348)Daig Corp.1980-05-28
DOSE CALIBRATION REF. SOURCES; BARIUM-13 (K800867)Amersham Corp.1980-05-28
DAHLBERG HEARING AID MODEL MEL (K801115)Dahlberg Electronics, Inc.1980-05-28
CONCEPT ENDOTRACHEAL TUBE (K801213)Concept, Inc.1980-05-28
LARGE SCREEN CRT DISPLAY #1311B (K801000)Hewlett-Packard Co.1980-05-28
HOLLOW BASKET TITANIUM DENTAL IMPLANT (K801208)Colmed, Ltd.1980-05-28
REAGENTS FOR DETERM. CHOLESTEROL/SERUM (K800682)Diagnostic Solutions, Inc.1980-05-28
DEN-MAT DENTIN BONDING AGENT (K801216)Den-Mat Corp.1980-05-28
J.T. BAKER NEPHELOMETER (K801089)J.T. Baker Chemical Co.1980-05-28
REAGENT FOR DETERM. DIRECT BILIRUBIN (K800686)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC (K800688)Diagnostic Solutions, Inc.1980-05-28
BITE BLOCK SYSTEM (K800760)Radiation Products Design, Inc.1980-05-28
LIBCO SUNGLASSES (K801196)Libco Eyewear, Inc.1980-05-28
MDS IMAGER (K801027)Medtronic Vascular1980-05-28
REAGENTS FOR DETERM. ALKALINE PHOSPHATAS (K800679)Diagnostic Solutions, Inc.1980-05-28
ATLAS-S X-RAY SYSTEM W/KETROMAT GEN. (K800998)General X-Ray, Inc.1980-05-28
REAGENTS FOR DETERM. SERUM IRON IN HUMAN (K800677)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. LACTATE/DEHYDROGENAS (K800691)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. GLUCOSE IN H/SERUM (K800687)Diagnostic Solutions, Inc.1980-05-28
RIAUSE AUTO PROCESSOR (K801030)Electro-Nucleonics Laboratories, Inc.1980-05-28
IL MODEL 773 FLUORESCENCE LIGHT SCATTER (K801026)Instrumentation Laboratory CO1980-05-28
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR (K800988)Novametrix Medical Systems, Inc.1980-05-28
ADAPTER KIT (K800353)Daig Corp.1980-05-28
REAGENTS FOR DETERM. CALCIUM IN HUMAN (K800680)Diagnostic Solutions, Inc.1980-05-28
LEAD, SUTURELESS MYOCARDIAL (K800355)Daig Corp.1980-05-28
AMBULATORY MONITOR AM-1 (K801001)Burdick Corp.1980-05-28
OTICON EARETTE HEARING AID #E17 HC (K801002)Oticon Corp.1980-05-28
XYLOSE LYSINE DESOXYCHOLATE AGAR (K800978)Quality Assurance Laboratory, Inc.1980-05-28
REAGENTS FOR DETERM. ALBUMIN IN HUMAN (K800678)Diagnostic Solutions, Inc.1980-05-28
MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA (K800869)Cavitron Corp.1980-05-28
REAGENT FOR DETERM. POTASSIUM/IN HUMAN (K800692)Diagnostic Solutions, Inc.1980-05-28
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM (K800673)Diagnostic Solutions, Inc.1980-05-28
COMPALOR-DENTAL MODEL (K801103)Narco Mckesson Co.1980-05-28
PACE-PULSE/COMPUTRAC (K800782)Bib, Inc.1980-05-28
KANDI-NUCLEAR MED. DATA ACQU.&INFO. (K800835)Krupp International, Inc.1980-05-28
NORMCAP CD-102, CARBON DIOXIDE ANALYZER (K801083)Instrumentarium-Datex1980-05-28
ANESTHESIA BREATHING CIRCUITS (K801191)Airlife, Inc.1980-05-28
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (K800674)Diagnostic Solutions, Inc.1980-05-28
PERM. INPLANT ENDOCARD. PAC. LEAD (K800347)Daig Corp.1980-05-28
DAHLBERG HEARING AID MODEL MEH (K801114)Dahlberg Electronics, Inc.1980-05-28
ROYAL (K800866)Trident Dental, Inc.1980-05-28
CAM-10 EXSUFFLATION BELT #11-001 (K800999)Lifecare Services, Inc.1980-05-28
AMES TDA AMIKACIN (K801130)Miles Laboratories, Inc.1980-05-28
PACEMAKER, ELECTRODE (K800352)Daig Corp.1980-05-28
P-NITROPHENYL PHOSPHATE (K801086)Macomb Chemical Co.1980-05-28
PEDIATRIC ANESTHESIA CIRCUIT (K801111)Vital Signs, Inc.1980-05-23
3M R.F. CURRENT SUPPRESSOR (K801041)3M Company1980-05-23
HYPERSTETHOSCOPE, MODEL Z 00 (K801165)Demonbinder Electronics1980-05-23
LANCER GLUCOSE RATE REAGENT KIT (K801071)Sherwood Medical Industries1980-05-23
DATA-ZYME GLUCOSE HEXOKINASE UV (K801052)Data Medical Associates, Inc.1980-05-23
CYCLOPAC CP100 TENS BANDAGE (K800576)Cyclotechnical Medical Indust., Inc.1980-05-23
NDM DIATEMP ELECTROSURGICAL DIS. PAD (K801158)Ndm Corp.1980-05-23
LIBERATOR/STROLLER II SYSTEM (K800742)Cryogenic Assoc.1980-05-23
R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) (K800935)R2 Corp.1980-05-23
SALMONELLA SHIGELLA AGAR (K800982)Quality Assurance Laboratory, Inc.1980-05-23
NEONATAL BREATHING CIRCUIT SYSTEM (K801087)Isothermal Systems, Inc.1980-05-23
R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 (K800936)R2 Corp.1980-05-23
MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) (K801005)National Catheter Co. Div. Mallinckrodt1980-05-23
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 (K800931)R2 Corp.1980-05-23
IL88640 & 88641 CASSETTE-TAPE PROGRAM (K801131)Instrumentation Laboratory CO1980-05-23
ROOMMATE-OXYGEN CONCENTRATOR (K801104)Cryogenic Assoc.1980-05-23
CYBREX GENTAMICIN (K801084)Abbott Laboratories1980-05-23
THIOGLYCOLLATE MED. W/O INDICATOR (K800985)Quality Assurance Laboratory, Inc.1980-05-23
ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 (K800932)R2 Corp.1980-05-23
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE (K800899)Miles Laboratories, Inc.1980-05-23
HEXTOEN ENTERIC AGAR (K800980)Quality Assurance Laboratory, Inc.1980-05-23
USCI INTRALUMINAL GRAFT W/DACRON TIE (K801156)C.R. Bard, Inc.1980-05-23
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI (K801051)Data Medical Associates, Inc.1980-05-23
R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 (K800937)R2 Corp.1980-05-23
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP (K801190)Airlife, Inc.1980-05-23
THAYER-MARTIN AGAR (K800977)Quality Assurance Laboratory, Inc.1980-05-23
EOSIN METHYLENE BLUE AGAR, LEVINE (K800984)Quality Assurance Laboratory, Inc.1980-05-23
BARRIER PLUS SURGEON GOWNS (K801162)American Hospital Supply Corp.1980-05-23
WINDSOR (K800865)Trident Dental, Inc.1980-05-23
MUELLER HINTIN AGAR W/5% SHEEP BLOOD (K800979)Quality Assurance Laboratory, Inc.1980-05-23
R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. (K800930)R2 Corp.1980-05-23
MACCONKEY AGAR (K800983)Quality Assurance Laboratory, Inc.1980-05-23
PLY LESIVE (K801047)May-Pell Chemical Development Co.1980-05-20
MODEL 5985 PACEMAKER PULSE GENERATOR (K800285)Medtronic Vascular1980-05-20
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Every clearance here is in the API, with alerts when new ones post.