Atlas FDA

1981

3,287 FDA 510(k) clearances · Clearance year

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RecordFirmDate
GILCHEM CALCIUM REAGENT (K812110)Gilford Diagnostics1981-08-13
SPACELABS' SYSTEM AUTORECORDER (K811540)Spacelabs, Inc.1981-08-13
BI-ASO SLIDE TEST (K812060)Biologics Intl., Inc.1981-08-13
AIRCAST PNEUMATIC KNEE BRACE (K812094)Aircast, Inc.1981-08-13
COBE HEAT EXCHANGER RESERVOIR MODULE (K812093)Cobe Laboratories, Inc.1981-08-13
GILCHEM CREATININE REAGENT (K812109)Gilford Diagnostics1981-08-13
SENSITITIRE AP60 (K811765)Gibco Laboratories Life Technologies, Inc.1981-08-13
LIFE-TECH #'S 1106/1156 UROLABS (K812178)Life-Tech Instruments, Inc.1981-08-13
MICRO-AIRE REPLACEMENT SAW BLADES (K811506)Micro-Aire Surgical Instruments, Inc.1981-08-13
BACH-SIMPSON MODEL BVM30 (K811615)Bach-Simpson , Ltd.1981-08-13
ULTRASONIC QFM SYSTEM 1000 (K811376)Narco Bio-Systems1981-08-13
AP X-RAY TUBE ANGULATION DEVICE (K811970)Philips Medical Systems (Cleveland), Inc.1981-08-13
POLI-AXIAL KNEE CAGE (K812064)Generation II Orthotics, Inc.1981-08-13
CORDIS DUCOR PTR SYSTEM (K811971)Cordis Corp.1981-08-13
ESOPHAGEAL MOTILITY APPARATUS (K812103)Honeywell, Inc.1981-08-13
BILE DISK (K812083)Remel Co.1981-08-13
KENL-ECG-3 (K811949)Suzuken Co., Ltd.1981-08-13
F72T12/BL-S/HO UVA SUNLAMP (K811585)Westinghouse Electric Corp.1981-08-13
CREATININE RATE REAGENT KIT (K811406)Chem-Elec, Inc.1981-08-13
DSS 500 (K811934)Philips Medical Systems (Cleveland), Inc.1981-08-13
MARRIA-HPRL RIA KIT (K812112)Intl. Immunoassay Laboratories, Inc.1981-08-13
HEMOTHERM MODEL 400 (K811742)Cincinnati Sub-Zero1981-08-13
EA 65 (K812086)Surgipath1981-08-13
AMERLEX TSH RIA KIT (K812136)Amersham Corp.1981-08-13
ASTRA (K811381)Chem-Elec, Inc.1981-08-13
CHLORIDE REAGENT KIT (K811319)Chem-Elec, Inc.1981-08-13
SPHGOMOMANOMETER (K812059)Med-Tek Corp.1981-08-13
MODIFIED THORACENTESIS CATHETER (K811437)Blair Medical Products1981-08-13
KENL-ECG (K811950)Suzuken Co., Ltd.1981-08-13
GLUCOSE OXIDASE RATE REAGENT (K811165)Chem-Elec, Inc.1981-08-13
RUBELLA LATEX CARD TEST (K811637)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-08-13
CP-625 SEE-THRU FILM CHANGER (K811967)Philips Medical Systems (Cleveland), Inc.1981-08-13
EA 50 (K812087)Surgipath1981-08-13
NEIA PAP ENZYMEIMMUNOASSAY (K811757)New England Immunology Assoc.1981-08-13
BACH-SIMPSON MODEL TS266 (K811616)Bach-Simpson , Ltd.1981-08-13
DUAL PEDESTAL TABLE (K811969)Philips Medical Systems (Cleveland), Inc.1981-08-13
COAT-A-COUNT DIGITOXIN RIA KIT (K812129)Diagnostic Products Corp.1981-08-13
GATOR DRAPES (K811996)The Anspach Effort, Inc.1981-08-13
ADAPTAID LEAD ADAPTER, #365-17 (K811920)Intermedics, Inc.1981-08-13
CASH ORTHOSIS (K812099)David Hendricks, C.P.O.1981-08-13
LIC 180 MEDICAL LAMPS (K812142)Lada Intl., Inc.1981-08-13
SPS DISK (K812084)Remel Co.1981-08-13
ARRHYTHMIA FUNCTION BLOCK (K811581)Honeywell, Inc.1981-08-13
XEROX 128 CASSETTE CHANGER (K812024)Xerox Medical Systems1981-08-13
USCI DOPPLER CATHETER SYSTEM (K810414)C.R. Bard, Inc.1981-08-12
INSPIRATORY FORCE PRESSURE ADAPTOR (K812067)Airlife, Inc.1981-08-12
ANTI-GM & ANTI-KM TYPING SERUMS (K812076)Biotest-Serum-Institut1981-08-12
SERALYZER (K812100)Miles Laboratories, Inc.1981-08-12
TECHNICON H6000 (90/HR) HEMATOLOGY SYS (K811978)Technicon Instruments Corp.1981-08-12
NICHOLE'S 99 (K812075)Healthcare Ind.1981-08-12
ANTI-SKIN ANTIBODY TEST SYSTEM (K811261)Zeus Scientific, Inc.1981-08-12
BLUING REAGENT (K811800)Richard-Allan Medical Ind., Inc.1981-08-12
SIMVAC (K811991)The Lynn Terrell Co.1981-08-12
LPC II (K812031)Labtronix Corp.1981-08-12
SP-100-B SMALL PARTS SCANNER SYSTEM (K811595)Highstoy1981-08-12
FAST CHOLES-CINET (K812091)Sclavo, Inc.1981-08-12
WAKO NEFA C TEST (K812081)Wako Chemicals USA, Inc.1981-08-12
MOORE HIP PROSTHESIS, PMMA COATED (K811416)Zimmer, Inc.1981-08-12
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST (K811613)Kent Laboratories, Inc.1981-08-12
SPECTRO FEIRITIN (K812056)Ramco Laboratories, Inc.1981-08-12
TEFLON PLEDGET SUTURE BUTTRESS (K811872)ETHICON, Inc.1981-08-12
DOPPLER ULTRASOUND BLOOD FLOWMETER (K811246)Irex Corp.1981-08-12
SICKLE CELL REAGENT SET (K811828)Anco Medical Reagents & Assoc.1981-08-12
ENDAB DIGOXIN KIT (K812054)Immunotech Corp.1981-08-12
UROSKOP C (K811807)Siemens Corp.1981-08-10
ARROW PERITONEAL LAVAGE CATHERIZATION K (K811627)Arrow Intl., Inc.1981-08-10
ATL'S MARK 100/300 ULTRASOUND SYSTEMS (K811572)Advanced Technology Laboratories, Inc.1981-08-10
MS-50 ULTRASONIC IMAGER (K811252)Kontron Instruments, Inc.1981-08-07
PLAYTEX COMBINATION FIBER MODIFIED TAMP (K811387)Playtex, Inc.1981-08-07
BACTASHIELD (K811859)Tri-Med, Inc.1981-08-07
PLAYTEX DIGITAL TAMPON (K811385)Playtex, Inc.1981-08-07
LAPAROTOMY PADS (K811769)South Mountain Medical1981-08-07
VISITEC NEDDLE TANGE (SURGERY) (K811960)Visitec Co.1981-08-07
IDS BETA-LACTAMASE DISC (K812047)Carr-Scarborough Microbiologicals, Inc.1981-08-07
PLAYTEX COTTON DIGITAL TAMPON (K811388)Playtex, Inc.1981-08-07
TIDAL VOLUME MONITOR 150 (K812046)Medix Medical Electronics (U.S.A.), Inc.1981-08-07
CROUCH CORNEAL PROTECTOR (K811577)Denver Biomedicals, Inc.1981-08-07
PLAYTEX COTTON TAMPONS (K811389)Playtex, Inc.1981-08-07
TYPE FH ENDOCARDIAL LEAD (K810494)Biotronik Sales, Inc.1981-08-07
NEUROGAR III (K812036)Inter Med Industries, Inc.1981-08-07
ADAPTAID LEAD ADAPTER #365-25 (K811938)Intermedics, Inc.1981-08-07
DISPOSABLE PILLOW (K812079)Carpenter Co.1981-08-04
CALIBRATED BREATHING SYSTEM COLLECTION (K811955)Anchor Brush Co., Inc.1981-08-04
BOUNDARY STERILIZATION WRAP (K811819)The Buckeye Cellulose Corp.1981-08-04
RESPIRATION RATE MONITOR 120/121 (K812044)Medix Medical Electronics (U.S.A.), Inc.1981-08-04
ISOLATER THP (K811981)Tri-Med, Inc.1981-08-04
PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (K812066)Airlife, Inc.1981-08-03
OREIA II, B-HCG (K811940)Organon, Inc.1981-08-03
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) (K812029)Eastman Kodak Company1981-08-03
ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR (K811758)Powers Medical Systmes1981-08-03
MODEL 84 TRANSPORT SYSTEM (K811372)Datascope Corp.1981-08-03
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) (K812030)Eastman Kodak Company1981-08-03
MODEL A UNIPOLAR ENDOCARDIAL LEAD (K811879)Cook Pacemaker Corp.1981-08-03
AXICARE BREAST SHELL (K811364)Neonatal Corp.1981-08-03
RADIOIMMUNOASSAY, FOLLICLE STIMULATING (K811993)Endocrine-Metabolic Center1981-08-03
NICHOLAS II, VIRAL-BACTERIAL FILTER (K811546)K & G Healthcare Ind., Inc.1981-08-03
KALLESTAD ANTISERA TO GENTAMICIN (K812050)Kallestad Laboratories, Inc.1981-08-03
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) (K812028)Eastman Kodak Company1981-08-03
PEDIATRIC DOUBLE SWIVEL CONNECTOR (K812000)Mallinckrodt Critical Care1981-08-03
MODEL C UNIPOLAR ENDOCARDIAL LEAD (K811877)Cook Pacemaker Corp.1981-08-03
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Every clearance here is in the API, with alerts when new ones post.