Atlas FDA

1980

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

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RecordFirmDate
MICROTHIN-PI (K800027)Cardiac Pacemakers, Inc.1980-01-31
PACING SYSTEM ANALYZER PSA SCE-22 (K791975)Ela Medical, Inc.1980-01-31
MINI-CEARS COMPUTER (MODEL 1) (K800001)Bik Foundation, Inc.1980-01-31
CYNERGY MODEL 182 (K792536)Cynergy1980-01-31
TELEMETRY SYSTEM XMT-1 & REC-1 (K792371)Burdick Corp.1980-01-31
MICROTHIN-DI (K800026)Cardiac Pacemakers, Inc.1980-01-31
H-H FIFTH VENTRICLE (K800168)Holter-Hausner Intl.1980-01-31
COULTER COUNTER MODEL S PLUS (K792537)Coulter Electronics, Inc.1980-01-29
ALKALINE PHOSPHATASE REAGENT (K792551)Electrophoresis Corp. of America1980-01-29
URIC ACID KIT (K792545)Alta Diagnostics, Inc.1980-01-29
RIONET HEARING AID HA-61 (K800012)Rion Acoustic Instruments, Inc.1980-01-29
PIXIE (K792665)Porta Ray, Inc.1980-01-29
1500 EO EXHAUST HOOD (K792660)Castle Co.1980-01-29
PACEMAKER ELECTRODE INSERTER AIDE (K800088)Telectronics, Inc.1980-01-29
UNISPORE-BIOLOGICAL INDICATORS (K792649)Castle Co.1980-01-29
LDC CONSTAMETRIC III HIGHT PRESS. SOL. (K800048)Laboratory Data Control1980-01-29
ALKALINE PHOSPHATASE MARKER (K792548)Electrophoresis Corp. of America1980-01-29
AGAROSE BARBITAL-EDTA BUFFER (K792553)Electrophoresis Corp. of America1980-01-29
M.P.I. LENS GLIDE (K792066)J. Leon Bilby1980-01-29
I.V. TAPE DOWN HOLDER (K800024)Consolidated Medical Equipment, Inc.1980-01-29
RIONET HEARING AID HE-71 (K800011)Rion Acoustic Instruments, Inc.1980-01-29
AGAROSE BARBITAL BUFFER (K792547)Electrophoresis Corp. of America1980-01-29
H-I-M-TEST FOR DETECTING HUMAN CHOR. GON (K800055)Technam, Inc.1980-01-29
COULTER COUNTER-BLOOD CELL COUNTER (K792668)Coulter Electronics, Inc.1980-01-29
RITTER MODEL J DENTAL CHAIR (K800084)Ritter Co.1980-01-29
CAMPY BLOOD AGAR (K792674)Regional Media Laboratories1980-01-28
HEMOCLIP SURGICAL OCCLUDING CLIP (K800079)Edward Weck, Inc.1980-01-28
STERILIZATION PROCESS/DBL. GRIP CORD CLP (K792631)Procter & Gamble Mfg. Co.1980-01-28
COMPUTED TOMOGRAPHY X-RAY SCANNER (K792603)Ohio Nuclear, Inc.1980-01-28
TRIOSKOP (K792645)Siemens Corp.1980-01-28
STANFORD STERILE LAP SPONGES (K800102)Lukens Corp.1980-01-28
HIGH RESOLUTION IMAGING SYSTEM (K792638)Unirad Corp.1980-01-28
HEXCEL FEMORAL COMPONENT HIP PROSTHESIS (K800051)Hexcel Medical1980-01-28
ANAGO ELECTRO SURGICAL TIP CLEANER (K800058)Anago, Inc.1980-01-28
STERILIZING CASE CAT. NO. 65199 (K800080)Edward Weck, Inc.1980-01-28
DIGITAL ELECTRONIC EXERCISER/PULSE MTR. (K800072)Sears, Roebuck & Co.1980-01-28
SURGICAL STITCH CUTTER (K800103)Macon & Co., Inc.1980-01-28
PORTARAY (K792535)Siemens Corp.1980-01-28
HYDRO PULSE MASSAGE (K792641)Hydro-Pulse Research, Inc.1980-01-28
STERILIZATION PROCESS/MATERNITY PAD (K792627)Procter & Gamble Mfg. Co.1980-01-28
PARA-PAK CLEAN VIAL (K792710)Meridian Diagnostics, Inc.1980-01-28
HILO TRANS-X TRAUMA TRANSPORT (K792326)Tecnomed, Inc.1980-01-28
VESSEL OCCLUDER (K800074)Cordis Corp.1980-01-28
THE VARIABLE LOAD KENETIC ENERGIZER (K792642)W.F. Pogue1980-01-28
CRUTCH TIPS, PADS & HAND GRIPS (K800076)New World Imports, Inc.1980-01-28
DAVOL/ABAMSON SILICONE SUMP DRAIN (K800081)Davol, Inc.1980-01-28
OBSTETRICAL BEDS (K792568)Ets Rene Marzet1980-01-28
HAMAS PRECENTERED TOTAL WRIST (K792650)Zimmer, Inc.1980-01-28
NIC-200 VENTRICULAR FUNCTION ANALYZER (K792466)Nicolet Biomedical Instruments1980-01-24
VASPAR SEALANT (K792702)Meridian Diagnostics, Inc.1980-01-24
PARA-PAK PVA (K792714)Meridian Diagnostics, Inc.1980-01-24
ANTI-GLOBULIN CONTROL (K792695)Meridian Diagnostics, Inc.1980-01-24
NORMAL GLOBULIN REAGENT (K792697)Meridian Diagnostics, Inc.1980-01-24
CAMPY THIO (K792676)Remel Co.1980-01-24
NOVAMETRIX CPAP NASAL CANNULA (K792722)Novametrix Medical Systems, Inc.1980-01-24
HELENA FACTOR XII DEFICIENT (K792656)Helena Laboratories1980-01-24
HELENA COLOSCREEN (K792655)Helena Laboratories1980-01-24
NEGATIVE CONTROL SERUM (K792694)Meridian Diagnostics, Inc.1980-01-24
CULTURETTE BRAND-PVA/FORMALIN KIT (K792654)Marion Laboratories, Inc.1980-01-24
KOH MOUNTING FLUID W/GLYCEROL (K792709)Meridian Diagnostics, Inc.1980-01-24
NEBULIZER TUBING SET (K800083)Abbott Laboratories1980-01-24
VENTILATOR TEST LUNG (K800125)Bio-Med Devices, Inc.1980-01-24
OUCHTERLONY AGAR PLATES (K792699)Meridian Diagnostics, Inc.1980-01-24
ANITOMIC TOTAL HIP SYSTEM (K800050)Hexcel Medical1980-01-24
IMMUNODIFFUSION BAND INTENSIFYING FLUID (K792692)Meridian Diagnostics, Inc.1980-01-24
VENTILATOR SET (K800056)Abbott Laboratories1980-01-24
CANDIDA ALBICANS, ANTIGEN (K792716)Meridian Diagnostics, Inc.1980-01-24
PARA-PAK(WHEATLEY'S TRICHROME STAIN) (K792706)Meridian Diagnostics, Inc.1980-01-24
LACTO-PHENOL ANALINE BLUE FLUID (K792703)Meridian Diagnostics, Inc.1980-01-24
NEONATAL HEATED HUMIDIFIER (K792620)Modern Medical Systems Co.1980-01-24
TRYPTIC SOY SXT AGAR W/SHEEP BLOOD (K792720)Gibco Laboratories Life Technologies, Inc.1980-01-23
PROVIT (K800060)Parker Laboratories, Inc.1980-01-23
HISTOPLASMA CAPSULATUM, ANTIGEN (K792701)Meridian Diagnostics, Inc.1980-01-23
DELTA TEST AMYLASE UV (K800049)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-01-23
BIOPHASE IMPLANT MATERIAL (K792329)Richard'S Medical Equip., Inc.1980-01-23
CUTTER POINTS (K792250)Cutter Laboratories, Inc.1980-01-23
INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS (K792469)Intersci Corp.1980-01-23
CARDIASSIST EXTERNAL COUNTERPULSATION (K792430)Cardiassist Corp.1980-01-23
KODAK EKTACHEM FOUR CHEMISTRY ANALYZER (K800053)Eastman Kodak Company1980-01-23
FIAX TEST KIT FOR GENTAMICIN QUAN. (K800032)Intl. Diagnostic Technology1980-01-23
BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION (K792683)Meridian Diagnostics, Inc.1980-01-23
WIDEX HEARING AID MODEL 820 (K792567)Widex Hearing Aid Co., Inc.1980-01-23
QUANTIMUNE CORTISOL RIA CORTISOL RADIO- (K800045)Bio-Rad1980-01-23
TELESONIC V-101 (K792644)Telesonic, Inc.1980-01-23
CANDIDA ALBICANS, ANTISERUM (K792713)Meridian Diagnostics, Inc.1980-01-23
WIDEX HEARING AID MODEL S10 (K792389)Widex Hearing Aid Co., Inc.1980-01-23
FLUOROMATIC PHENOLBARBITAL FIA (K800090)Bio-Rad1980-01-23
HEARING AID, MODELS DRI-35/DL1-35 (K792643)Unitron Industries, Inc.1980-01-23
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD (K792249)Intl. Diagnostic Technology1980-01-23
COE-SIL (K792428)Coe Laboratories, Inc.1980-01-23
PARA-PAK FORMALIN (K792705)Meridian Diagnostics, Inc.1980-01-21
LITHIUM STANDARD (1MM/L) (K800042)Gilford Diagnostics1980-01-21
ALT REAGENT (K800038)Gilford Diagnostics1980-01-21
BK-1544 BE OK SCOOP DISK (K800019)Fred Sammons, Inc.1980-01-21
CESIUM DILUENT (1.5 MM/L) (K800043)Gilford Diagnostics1980-01-21
MOPSO BUFFER (K792574)Electrophoresis Corp. of America1980-01-21
PARA-PAK SAF (K792707)Meridian Diagnostics, Inc.1980-01-21
BK-5203 FACILITATION VIBRATOR ELECTRIC (K800018)Fred Sammons, Inc.1980-01-21
COLOR CODED PUTTY SOFT, REGULAR & FIRM (K800017)Fred Sammons, Inc.1980-01-21
BLOOD FLUID FILTERS (K792723)Dade, Baxter Travenol Diagnostics, Inc.1980-01-21
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