Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SIEGEN VISUAL STIMULATOR (K844616)Siegen Corp.1985-02-14
SPACELABS MODEL 90201 HOLTER RECORDER (K844940)Spacelabs, Inc.1985-02-14
CARDIOTOMY RESERVOIR W/FILTER (K843595)Omnis Surgical, Inc.1985-02-14
YKI-770 ELECTRONIC SPHYGMOMAMETER (K842318)Yukosha Co., Inc.1985-02-14
PERITONEAL DIALYSIS COIL CATHETER (K850247)Sil-Med Corp.1985-02-14
BODYSCREEN II (K843851)Erich Jaeger, Inc.1985-02-14
COPAL DIGITAL SPHYGMOMANOMETER UA-510 (K842388)Takeda Medical, Inc.1985-02-13
SACRAL BAR (K843445)Stuart1985-02-13
COMPUTER (K844665)Burdick Corp.1985-02-13
LIFESOUND - ELECTRONIC STETHOSCOPE (K844804)Biomedical Concepts, Inc.1985-02-13
AGEE EXTERNAL FIXATOR (K842493)The Hand Biomechanics Research Laboratory1985-02-13
AUTO DII MULTI FREQUENCY (K844293)Technicare Corp.1985-02-13
PULSED DOPPLER OPTION, CONTINU-WAVE (K842407)General Electric Co.1985-02-13
VINGMED DS100 DOPPLER FLOWMETER (K843933)Vingmed, Inc.1985-02-13
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT (K844740)Hewlett-Packard Co.1985-02-12
OHMEDA DOUBLE SWIVEL ADAPTER (K844656)Ohmeda Medical1985-02-12
INTERMED, INS STERILE WATER/SALINE (K842166)Intermed, Inc.1985-02-12
GLUCOCHEK III (K842474)Larken Industries, Inc.1985-02-12
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE (K844564)Sherwood Medical Co.1985-02-12
LORD SCREW RING ACETABULAR COMPONENT (K844028)Howmedica Corp.1985-02-12
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN (K844914)Abbott Laboratories1985-02-12
ENZYGNOST LIPASE TEST (K844240)Behring Diagnostics, Inc.1985-02-12
MOBILIZATION & TRACTION TABLE (K844359)Chattanooga Group, Inc.1985-02-12
SIREDOC, PAPER CHART RECORDER (K850146)Siemens Medical Solutions USA, Inc.1985-02-12
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT (K850319)Sigma Diagnostics, Inc.1985-02-12
PROBEYE THERMAL VIDEO SYSTEMS (K843549)Hughes Aircraft Co.1985-02-11
HMB ALLERGOGEN SKIN PRICK TEST NEEDLE (K844221)Aller/Guard, Inc.1985-02-08
COPAL DIGITAL SPHYGMOMANOMETER UA-540 (K844284)Takeda Medical, Inc.1985-02-08
IABP #90 SYSTEM (K831235)Datascope Corp.1985-02-08
PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS) (K850193)Degussa Dental, Inc.1985-02-08
COLTENE PRECISE (K850036)Coltene, Inc.1985-02-08
CENTURY SAF-LIFT SCALE (K844871)Century Manufacturing Co.1985-02-08
GDC-1489 A CASTING ALLOY (K850103)Deringer-Ney, Inc.1985-02-08
CARDIOBEEPER PROFILE MONITOR (K844966)Survival Technology, Inc.1985-02-08
GDC-1433 A CASTING ALLOY (K850102)Deringer-Ney, Inc.1985-02-08
MDE ESCORT 1000 & MDE ESCOR 2000 (K842716)Medical Data Electronics1985-02-08
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR (K844793)Intermedics, Inc.1985-02-08
BIOPATCH BOVINE PERICARDIAL PATCH (K840756)Meadox Medicals, Div. Boston Scientific Corp.1985-02-08
ELECTROCARDIOGRAPH-ECG CALIPER (K850021)Devcom, Inc.1985-02-08
CARDIOGUARD STRESS TEST MONITOR 4002 (K850043)Del Mar Avionics1985-02-08
VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE (K844471)Dentsply Intl.1985-02-08
BRAUN DENTAL CENTER OC-3 (K844339)The Braun Corp.1985-02-08
CENTURY SCALE (K844872)Century Manufacturing Co.1985-02-08
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT (K850073)Johnson & Johnson Professionals, Inc.1985-02-08
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE (K844958)Medtronic Vascular1985-02-08
GDC-1629 A CASTING ALLOY (K850101)Deringer-Ney, Inc.1985-02-08
PERCOR 9.5 FR IAB ON DATASCOPE CO2 (K833828)Datascope Corp.1985-02-08
C/PES 9103, ECG STRESS TESTING SYSTEM (K850113)Gould, Inc.1985-02-08
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR (K844957)Medtronic Vascular1985-02-08
SYNATOMIC STANDARD TIBIAL PLATEAU (K844355)Depuy, Inc.1985-02-07
ACE INTRAMEDULLARY ROD FOR SMALL BONES (K850142)Buckman Co., Inc.1985-02-07
BCS POTASSIUM TURBIDIMETRIC TEST (K850258)Bioclinical Systems, Inc.1985-02-07
EPICHROME PAP (K844968)Cetus Corp.1985-02-07
BREWER HEAVE-DUTY I.V. STAND W/FOOT OPERATED PNUEM (K850245)E.F. Brewer Co.1985-02-07
DONWAY SPLINT (K843522)Australian Biomedical Corporation , Ltd.1985-02-07
ISOCONTROL SERUM LD- (K850211)Sclavo, Inc.1985-02-07
COPAL DIGITAL THERMOMETER UF-22B (K850196)Takeda Medical, Inc.1985-02-07
TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE (K844917)Turn Needle Intl., Inc.1985-02-07
COPAL DIGITAL THERMOMETER UF-12 (K850195)Takeda Medical, Inc.1985-02-07
BIOTRONIK DNP UNIPOLAR (K841450)Biotronik Sales, Inc.1985-02-07
ISOENZYME TEST CK-MB (K850212)Sclavo, Inc.1985-02-07
ORIGINAL REGULAR TAMPAX TAMPONS (K844935)Tambrands, Inc.1985-02-07
SUPER TAMPAX TAMPONS (K844936)Tambrands, Inc.1985-02-07
FLUOROSCAN/TM BY HEALTHMATE (K843920)Healthmate, Inc.1985-02-07
SOLEO SUNBED (K844788)Hapro International B.V.1985-02-07
QUIKPAGE ARRHYTHMIA REPORT GENERATOR (K841083)Agilent Technologies1985-02-07
BIOTRONIK DY-UNIPOLAR (K841451)Biotronik Sales, Inc.1985-02-07
ANTERIOR CRUCIATE LIGAMENT GRASPER (K841241)Surgical Products Corp.1985-02-06
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL (K844115)Medtronic Vascular1985-02-06
TDX ETHOSUXIMIDE (K850174)Abbott Laboratories1985-02-06
IMAGEN CHLAMYDIA TEST (K844683)Boots-Celltech Diagnostics, Inc.1985-02-06
CALCIUM (K850281)Boehringer Mannheim Corp.1985-02-06
SPECIMEN COLLECTION & TRANSPORT SYSTEM (K844475)Portable Medical Laboratories, Inc.1985-02-06
CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAY (K850140)Corning Medical & Scientific1985-02-06
ARGON/KRYPTON LASER SYSTEM 8500 (K844209)Cooper Lasersonics, Inc.1985-02-06
ACTIVE CORTISOL DSL 2000-SP (K850141)Diagnostic Systems Laboratories, Inc.1985-02-06
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT (K850056)Leeco Diagnostics, Inc.1985-02-06
SURGICAL MODULE 7000 ECG (K840869)Marquette Electronics, Inc.1985-02-06
MICRO ORGANISM GROWTH SYS-M1000 (K843000)Hml Inc/Biotechnology Transfer1985-02-06
PARAGON TRICHECK ELECTROPHORESIS CONTROL (K844996)Beckman Instruments, Inc.1985-02-06
GELMAN TRIPHOR CONTROL (K850202)Gelman Sciences, Inc.1985-02-06
PALMER OBSTETIC BRACE (K844183)Mic Medical Corp.1985-02-04
IREX PS, PORTABLE SCANNER AND 118 (K844404)Irex Corp.1985-02-04
CORNING CALCIUM PH ANALYZER 634 (K844188)Corning Medical & Scientific1985-02-04
OXYGEN CONCENTRATOR (K850346)Inspiron Corp.1985-02-04
CANMED 103 (K844098)Medtronic Vascular1985-02-04
SERATEST ENA(RNP/SM) DETERMINATION (K844743)Seragen Diagnostics, Inc.1985-02-04
MINUTEMAN CO2 MICROSURGICAL LASER GYN (K843515)American Surgical Laser, Inc.1985-02-04
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP (K844307)Egnell, Inc.1985-02-04
CORDIA IC (K844294)Cordis Corp.1985-02-04
VISION TRIGLYCERIDES (K850031)Abbott Laboratories1985-02-04
ARTERIAL EXTENSION SET (K850088)Medical Matrix, Inc.1985-02-02
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB (K844781)Shaban Mfg. Co.1985-02-01
SYSTE MATE TIBC HEM NO. 67225 (K850128)Em Diagnostic Systems, Inc.1985-02-01
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (K843828)Roche Diagnostic Systems, Inc.1985-02-01
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (K844767)Biotecx Laboratories, Inc.1985-02-01
AQUAFORM ELECTRODES WITH AQUAPORE (K844023)Biostim, Inc.1985-02-01
ARRHYTHMIA SYSTEM AC-11 (K841084)Fukuda Denshi USA, Inc.1985-02-01
MEDTRONIC MODEL 6912 (K844687)Medtronic Vascular1985-02-01
CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM (K850136)Cardio Data1985-02-01
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