Atlas FDA

1983

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

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RecordFirmDate
HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK (K833665)J.S. Medical Assoc.1983-11-25
HEMATOLOGY WRIGHT'S STAIN PACK (K833678)J.S. Medical Assoc.1983-11-25
EVOKED POTENTIALS SYSTEM MK10 (K832510)Amplaid USA, Inc.1983-11-25
ELASTOPLAST (K831438)Beiersdorf, Inc.1983-11-25
EARLY PREGNANCY DETECTION TEST KIT (K833466)Quidel Corp.1983-11-25
DUPONT LINEARIZATION MODULE (K832746)E.I. Dupont DE Nemours & Co., Inc.1983-11-25
NEBULIZER ACCESSORY FOR SERVO VENTILL (K832898)Siemens Elema AB1983-11-25
SERVO HEATED RESPIRATORY HUMIDIFIER (K832928)Fisher & Paykel Allied Products , Ltd.1983-11-25
HEIFETZ INTRACRANIAL ANEURYSM CLIPS (K832795)Edward Weck, Inc.1983-11-25
SERUM CHOLINESTERASE REAGENT SET (K833062)Sterling Biochemical, Inc.1983-11-25
BX-600 EMS (K832976)Bloomex International, Inc.1983-11-25
REAGENT SET TRIGLYCERIDES GPO (K833082)Boehringer Mannheim Corp.1983-11-25
POTASSIUM ELECTRODE TIP ASSAMBLY-K- (K833159)Hi Chem, Inc.1983-11-25
TOOTH SLOOTH (K833338)Joel Lander D.D.S.1983-11-25
GOLD FILM MERCURY ANALYZER #511 (K832933)Jerome Instrument Corp.1983-11-25
POLYSTYRENE MICROTITER WELL IMMUNOSOR (K832345)Diagnostic Reagent Tech.1983-11-25
OXYGEN CONCENTRATOR RESPIRATORY SUPPOR (K831819)Eagle Medical Equipment Co.1983-11-22
DONALDSON VENT TUBE (K823910)Treace Medical, Inc.1983-11-22
STAODYN EMS/PLUS (K832988)Staodynamics, Inc.1983-11-22
GASLINE FILTER, #EC-GLF SERIES (K832935)Gish Biomedical, Inc.1983-11-22
TSH RIA (K833910)Syncor Intl. Corp.1983-11-22
REGISTREX 1000 DIGITAL RADIOGRAPHY SYS (K833230)Advanced Technology Laboratories, Inc.1983-11-21
INNOVATIVE HEARING CORP. #IHC 1000 (K832633)Innovative Hearing Corp.1983-11-21
DESERET ANGIO-GUIDE LARGE VEIN CATH. (K833092)Warner-Lambert Co.1983-11-21
HEARING AID, UNITRON UT1 (K833614)Unitron Industries, Inc.1983-11-21
ALPHA-I (K832642)Johnson Flexgroup1983-11-21
CLEX (K833463)Dextran Products, Ltd.1983-11-21
DIACROM *PLG (K832591)Wellcome Diagnostics1983-11-21
DESERET SUBCLAVIAN JUGULAR CATH-SET (K833091)Warner-Lambert Co.1983-11-21
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM (K833530)General Electric Co.1983-11-21
PERSONAL AMPLIFIER (K832168)Electone, Inc.1983-11-21
INTRACATH INTRAVENOUS CATHETER UNIT (K833135)Parke-Davis Co.1983-11-21
C-FLEX MEDICAL GRADE TUBING (K833076)Concept, Inc.1983-11-21
CEMAX-1000 (K833525)Contour Medical Systems, Inc.1983-11-21
CAPNOMETER W/NEW AIRWAY ADAPTER 47210A (K831447)Hewlett-Packard Co.1983-11-21
ECG-GEL ELECTRODE GEL (K833172)Whs Products, Inc.1983-11-21
PORTA. X-RAY UNIT FP220 SCM-1-ETC, (K833239)Showa X-Ray Co., Ltd.1983-11-21
POLYSTYRENE MICROTITER PLATE IMMUNO- (K832344)Diagnostic Reagent Tech.1983-11-21
HEARING AID UNITRON UI3 (K833615)Unitron Industries, Inc.1983-11-21
TRAVASPORE BIOLOGICAL INDICATOR (K832922)Travenol Laboratories, S.A.1983-11-21
REPORTING INTEGRATOR 3392A (K833113)Hewlett-Packard Co.1983-11-21
POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (K831984)Diagnostic Reagent Tech.1983-11-21
COLOSCREEN V.P.I. (K832864)Helena Laboratories1983-11-21
TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (K833129)Tago, Inc.1983-11-21
OPTHALMIC ENDOSCOPE (K832405)Cilco, Inc.1983-11-21
NUK BREAST SHIELD (K833450)Reliance Products Corp.1983-11-21
AUTOIMMUNE TEST 1/2/3 SYSTEM (K833119)Atlantic Antibodies1983-11-21
VENTRESCREEN BETA-HCG ENZYME IMMUNO (K833909)Vxr, Inc.1983-11-21
ENZYME ANA TEST SYSTEM (K833148)Immuno Concepts, Inc.1983-11-21
TOP VENULA I.V. CATHETER SET (K832624)Top Surgical Manufacturers Co.1983-11-21
C.B. RADIOLOGY DESIGN GONADSHIELD (K833523)Radiology Design1983-11-21
POCKET AID (K832702)M.C. Johnson Co., Inc.1983-11-17
SERVOMED BASIC BEDSIDE UNIT SMVIII W (K831781)Litton Medical Electronics1983-11-16
SERVOMED BASIC BEDSIDE UNIT SMV 104 (K831783)Litton Medical Electronics1983-11-16
SERVOMED COMPACT MONITOR SMK 155-9 (K832035)Litton Medical Electronics1983-11-16
SERVOMED SMC 108/111-426-24, 111-426 (K832022)Litton Medical Electronics1983-11-16
SERVOMED CENTRAL STATION SMV 206 (K832131)Litton Medical Electronics1983-11-16
SERVOMED BASIC BEDSIDE UNIT SMV 107 (K831782)Litton Medical Electronics1983-11-16
SERVOMED COMPACT MONITOR SMK 154-8/101 (K832021)Litton Medical Electronics1983-11-16
ASAHI HOLLOW FIBER KIDNEYS, EXCEL (K833150)Asahi Medical Co., Ltd.1983-11-15
PACEMAKER SYS. ANALYZER 378 (K832959)Siemens Elema AB1983-11-14
DIGITAL INJECTOR SYS (K833138)Sybron Corp.1983-11-14
SINGLE BED ARRHYTHMIA MONITOR AM500 (K831638)Lifeline Systems, Inc.1983-11-14
ENCODYNE 4 & VACUFIX 4 (K832393)Elmed, Inc.1983-11-14
PANASONIC WH-50 HEARING AID (K833510)Panasonic Co. Div. Matsu Elec. Corp. America1983-11-14
DISPOSABLE ARTHROSCOPY BLADE (K833587)Dyonics, Inc.1983-11-14
MUTO BRUSH (K833330)Microvasive1983-11-14
IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (K832900)Bionetic Laboratory Products1983-11-14
SOFFBAN ORTHOPEDIC PADDING (K832992)Smith & Nephew, Inc.1983-11-14
BOUINS SOLUTION (K833515)Sigma Chemical Co.1983-11-14
VASCULAR LABORATORY TREADMILL VT1 (K833588)Medasonics, Inc.1983-11-14
LARYNGOSCOPE BLADES/HANDLES & LAMPS (K833055)Medovations, Inc.1983-11-14
BOYLE SYSTEM ANESTHESIA GAS MACHINE (K833151)Fraser Harlake, Inc.1983-11-14
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT (K832914)Intermedics, Inc.1983-11-14
PERIPHERAL TRANSLUMINAL ARGIOPLASTY (K832279)Sontek Corp.1983-11-14
MODULUS II ANESTHESIA GAS MACHINE (K833335)Ohio Medical Products1983-11-14
TDX THEOPHYLLINE (K833070)Abbott Laboratories1983-11-14
FOAM HELMET - USE W/ESOPHAGEAL TAMPONA (K832859)Inmed Corp.1983-11-14
ASPIRATION & IRRIGATION CATHETER (K833331)Microvasive1983-11-14
BETA SCAN REAGENT STRIP (K832691)Orange Medical Instruments, Inc.1983-11-14
SPECIFIC ATLAS MICROJUST (K833324)Haygood Scientific Tool Co.1983-11-14
PNEU PAC VENTILATOR/RESUSCITATORS (K832700)Pneupac , Ltd.1983-11-14
LABOR/DELIVERY/RECOVERY BED LDR-600 (K833321)Adel Medical , Ltd.1983-11-14
RXG (K833052)Jeneric Ind.1983-11-14
BP TRANSDUCER HOLDERS TH-2,3 & 4 (K832384)American Bentley1983-11-14
PARAMAX BILIRUBIN CALIBRATORS (K833005)American Dade1983-11-14
TRANCOJECT DISPOSABLE SYRINGES (K832605)Huborga, Inc.1983-11-14
BEHIND THE EAR ASP-BB (K833334)Omni Hearing Systems1983-11-14
BACTERUERIA SCREENING PROCEDURE (K832975)Turner Designs, Inc.1983-11-14
DEFAZOLIN 30MCG. SENSITIVITY DISCS (K832910)Difco Laboratories, Inc.1983-11-14
GONOCHEK-II (K833180)E-Y Laboratories, Inc.1983-11-14
TEL-STAR NUWAY & GENERIC E ASP-BP (K833451)Omni Hearing Systems1983-11-14
CASE-II (K833458)Marquette Electronics, Inc.1983-11-14
RIONET HEARING AID HB-345 (K833134)Rion Acoustic Instruments, Inc.1983-11-14
Y CERAMIC (K833053)Jeneric Ind.1983-11-14
ELECTRO-PULSE (K832160)Electro-Pulse1983-11-14
INIVOX ELECTRODE/CATHETER SYS (K832916)Critikon Company, LLC1983-11-14
TECHNICON RA-1000 SYS-ISE MODULE & (K833072)Technicon Instruments Corp.1983-11-14
PERMALUX VISIBLE CURE COMPOSITE RESTOR (K831351)Lares Manufacturing Co., Inc.1983-11-14
LACTABACILLUS AGAR W/O TWEEN80 (K833292)Acumedia Manufacturers, Inc.1983-11-14
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Every clearance here is in the API, with alerts when new ones post.