Atlas FDA

1985

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

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RecordFirmDate
ARTHOPOR-ACETABULAR COMPONENT (K844050)Joint Medical Products Corp.1985-12-06
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE (K853419)Hood Laboratories1985-12-06
AMIZYME-CMV KIT (K842529)Amico Lab, Inc.1985-12-06
PENICILLIN/STREPTOMYCIN SOLUTION (K854567)Mediatech, Inc.1985-12-06
MINI MASH 2000 (K854602)Dynatech Corp.1985-12-06
AMIZYME-EBV TEST KIT (K842530)Amico Lab, Inc.1985-12-06
CHURCHILL-H NON-VENTED IV SET (K854435)Churchill Corp.1985-12-05
TERUMO SENSIBEAD EIA COLORIMETER (K854210)Terumo Medical Corp.1985-12-05
ULTRAZYME PLUS & SYSTEMATE LDH (K854585)Em Diagnostic Systems, Inc.1985-12-05
COMPUTERIZED RADIATION TREATMENT PLANNING SYS (K853964)Computerized Medical Systems, Inc.1985-12-05
REPLACEMENT PUMP TUBING (K853621)Shaban Mfg. Co.1985-12-05
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT (K854324)Pantex, Div. Bio-Analysis, Inc.1985-12-05
CHURCHILL-H SCALP VEIN SET (K854436)Churchill Corp.1985-12-05
LBK 1244 DELFIA HCG KIT (K852760)Lkb Instruments, Inc.1985-12-05
I.V. WATCH (K854172)Alltek, Inc.1985-12-05
CHURCHILL-H VENTED IV SET (K854437)Churchill Corp.1985-12-05
ABBOTT STREP A P.S.D. (K852266)Abbott Laboratories1985-12-05
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE (K854057)Beckman Instruments, Inc.1985-12-05
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY) (K854104)Immunchem Corp.1985-12-05
RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR (K853848)Medical Graphics Corp.1985-12-05
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT. (K854608)Nova Biomedical Corp.1985-12-05
ADDITIVE EXTENSION SYRINGE (K853120)Abbott Laboratories1985-12-05
TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU (K854392)Windsor Laboratories, Inc.1985-12-05
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (K854377)Hemotec, Inc.1985-12-04
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD (K854405)Pacesetter Systems1985-12-04
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A (K852710)Telectronics, Inc.1985-12-04
ELECTROLYTE ANALYZER SERA-252 (K853405)Horiba Instruments, Inc.1985-12-04
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT (K853695)Viromed Laboratories, Inc.1985-12-04
KONTRON DEFIBRILLATOR 7501 (K854307)Kontron Instruments, Inc.1985-12-04
NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC (K852976)American Micro Scan1985-12-04
EXPLORER (K853850)Mansfield Scientific, Inc.1985-12-04
POLYFLEX IMPLANTABLE PACING LEAD-476-07 (K853521)Intermedics, Inc.1985-12-04
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08 (K853517)Intermedics, Inc.1985-12-04
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD (K854220)Pacesetter Systems1985-12-04
CK(OPTIMIZED) REAGENT (K854501)Sigma Diagnostics, Inc.1985-12-04
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA (K853294)Cardiac Control Systems, Inc.1985-12-04
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS (K854376)Hemotec, Inc.1985-12-04
MEDTRONIC MODEL 5062 (K853398)Medtronic Vascular1985-12-04
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD (K854071)Intermedics, Inc.1985-12-04
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES (K854261)Advanced Cardiovascular Systems, Inc.1985-12-04
TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 (K853719)Electro Therapeutic Devices, Inc.1985-12-04
CARDIAC COMMUNICATOR 2000 (K852654)Creative Medical, Inc.1985-12-04
ARRHYTHMIA REVIEW STATION (K854136)Marquette Electronics, Inc.1985-12-04
TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804 (K853718)Electro Therapeutic Devices, Inc.1985-12-04
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN (K854184)Clinical Data, Inc.1985-12-04
ACS INDEFLATOR (MODIFICATION) (K854310)Advanced Cardiovascular Systems, Inc.1985-12-04
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM (K851365)Sorin Biomedica, Fiat, USA, Inc.1985-12-03
NEOGUARD CHEST PERCUSSOR (K853965)Cas Medical Systems, Inc.1985-12-03
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI (K853914)Pacesetter Systems1985-12-03
PY-RITE (K853758)Golden Dental Products, Inc.1985-12-03
TENS CONDUCTIVE MEDIA PAD (K853633)Alternative Design Systems, Inc.1985-12-03
AN PRESSURE MONITOR (K852826)Ferguson Medical1985-12-03
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) (K853136)E.A. Fischione Instrument Mfg.1985-12-03
PMA PRESSURE MONITOR (K852824)Ferguson Medical1985-12-03
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS (K854132)Cook Pacemaker Corp.1985-12-03
L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION (K853099)L.O.N. Research, Inc.1985-12-03
ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC (K854137)Arrow Intl., Inc.1985-12-03
TMA TEMPERATURE MONITOR (K852825)Ferguson Medical1985-12-03
CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN (K853383)Webster Laboratories, Inc.1985-12-03
SERIES 2000 MEDS MASK (K853785)Med Systems1985-12-03
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE (K854214)Cordis Corp.1985-12-03
HEADSTRAP (K854537)Life Design Systems, Inc.1985-12-03
AMERICAN PHARMASEAL HUMIDAIR CONDENSER (K854012)American Pharmaseal Div. Ahsc1985-12-03
ADULT VENTILATOR TESTER VT-1 (K853760)Bio-Tek Instruments, Inc.1985-12-03
FOUR CHANNEL PH PROBE (K853280)Akron City Hospital1985-12-02
1351 UROFLOW AUTO START (K853936)Life-Tech Intl., Inc.1985-12-02
TUBING CLAMP CAT#1000-A (K854512)Rao Medical Devices, Inc.1985-12-02
SONOLAYER-L, SAL-77A (K852090)Toshiba Medical Systems1985-12-02
MODIFIED AM-SERIES DIALYZERS (K854575)Asahi Medical Co., Ltd.1985-12-02
AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER (K854028)Verified Medical Research, Inc.1985-12-02
THE TRAVENOL 5 ML/HR INFUSOR (K853881)Travenol Laboratories, S.A.1985-12-02
ROTEX SCREW BIOPSY NEEDLE (K854404)Meadox Surgimed, Inc.1985-12-02
BLADE, SCALPEL (K854561)Medelec Intl. Corp.1985-12-02
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA (K853925)Nms Pharmaceuticals, Inc.1985-12-02
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (K854517)Travenol Laboratories, S.A.1985-12-02
NEW OPTIONAL PROBES FOR SSA-90A (K852159)Toshiba Medical Systems1985-12-02
WIDEX MODEL M1 (K853793)Widex Hearing Aid Co., Inc.1985-12-02
FLOSPIK (K853767)Medelco , Ltd.1985-12-02
V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (K854568)American V. Mueller1985-12-02
MAGNETIC RETRIEVER (K854281)Aspen Laboratories, Inc.1985-12-02
VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON (K854497)Canadian Wheelchair1985-12-02
MALIS IRRIGATION SYSTEM (K854413)Valley Forge Scientific Corp.1985-12-02
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM (K854027)Laserscope1985-12-02
DYNAFEED (K854215)Medline Industries, Inc.1985-12-02
DEPEND FITTED BRIEF (K854378)Kimberly-Clark Corp.1985-12-02
VISTA MED-URISTAT (K853892)Vista Med1985-12-02
ELF (K853433)Cardio-Respiratory1985-11-29
PENOX HIGH FLOW MANIFOLD (K853775)Penox Technologies, Inc.1985-11-29
IN A WINK LUBRICATING & REWETTING DROPS (K853445)Ciba Vision Care1985-11-29
PO-510 TCPO2 MONITOR (K852959)Sumitomo Electric Industries, Inc.1985-11-29
EDEC 2000 (K852908)Electromed Intl., Ltd.1985-11-29
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (K850683)Kent Laboratories, Inc.1985-11-27
NYSTAGMOGRAPH EOG/ENG ANALYSES (K851190)Nicolet Biomedical Instruments1985-11-27
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT (K854049)American V. Mueller1985-11-27
VICKERS MEDICAL MODEL 273 OXYGEN MONITOR (K854599)Vickers , Ltd.1985-11-27
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE (K854474)Cordis Corp.1985-11-27
MEDSURG ULTRASOUND BIOPSY TRAY (K854289)Medsurg Industries, Inc.1985-11-26
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF (K842830)Bartels Immunodiagnostic Supplies, Inc.1985-11-26
TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT (K852704)Clincal Instruments Corp.1985-11-26
PLATELET-TROL II (K854353)R&D Systems, Inc.1985-11-26
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Track 1985 automatically

Every clearance here is in the API, with alerts when new ones post.