Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
FILTER PURGE LINE EC-FPL SERIES (K833644)Gish Biomedical, Inc.1984-12-29
PHOTIC STIMULATOR TM-3030-70 (K842964)Tracor Northern, Inc.1984-12-28
SERVO VENTILATOR 900D SIEMENS-ELEMA AB (K844912)Siemens Elema AB1984-12-28
SECURIPIN (K844457)Hughes Int'L, Inc.1984-12-27
EBNA ACIF KIT (K840417)Litton Bionetics1984-12-27
MENSTRUAL PADS (K844035)American Disposable Products Corp.1984-12-27
VENOUS RESERVOIR-BMR-1500-HARD SHELL (K842373)American Bentley1984-12-27
THE GENERIC OXYGEN CONCENTRATOR (K844852)Proto-Med, Inc.1984-12-27
NEWPORT VENTILATOR MODEL E-100 (K844350)Newport Medical Instruments, Inc.1984-12-27
ERGO-OXYSCREEN (K843841)Erich Jaeger, Inc.1984-12-27
STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN (K844137)Shiley, Inc.1984-12-27
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH (K844003)Electro-Catheter Corp.1984-12-27
MYOCARDIAL INSULATOR (K843983)Norton Texas Medical Products1984-12-27
OXYSCREEN (K843860)Erich Jaeger, Inc.1984-12-27
MEADOX SURGIMED A/S CATHETER SHEATH SYS (K843798)Meadox Surgimed, Inc.1984-12-27
RT-50 (K843320)General Electric Co.1984-12-27
ECG PATIENT MONITOR (K843376)Rigel Medical Electronics, Inc.1984-12-27
STOCKERT-SHILEY INTRACARDIAC SUCKERS (K844139)Shiley, Inc.1984-12-27
ANTI-LEU-4 FITC LYSIN C BUFFER (K842218)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-27
CORDIS ENCOR ATRIAL LEAD (K811259)Cordis Corp.1984-12-27
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR (K843802)Shiley, Inc.1984-12-27
CANMED 101 (K844100)Medtronic Vascular1984-12-27
CANMED 102 (K844099)Medtronic Vascular1984-12-27
MEDTRONIC 6957 (K843706)Medtronic Vascular1984-12-27
OSTEOGEN (K843398)Impladent1984-12-27
NELLCOR PULSE OXIMETER N-10 (K844256)Nellcor, Inc.1984-12-27
STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH (K844140)Shiley, Inc.1984-12-27
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI (K844138)Shiley, Inc.1984-12-27
SITE ULTRASONIC EMULSIFICATION MODULE OP (K844666)Chiron Vision Corp.1984-12-27
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS (K844197)Nidek, Inc.1984-12-24
MIC-BIO-PLATE (K844903)Pasco Laboratories, Inc.1984-12-24
ME-TOO OXYGEN CONCENTRATOR (K844312)Medequip Co.1984-12-24
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE (K844198)Nidek, Inc.1984-12-24
PREMIER O2 OXYGEN CONCENTRATOR (K844223)Everest & Jennings, Inc.1984-12-24
VIBRAMETER (K843486)Somedic AB1984-12-24
MEDIPART XENON BREATHING KIT MP-01XM (K844496)Medipart Jerry Alexander1984-12-24
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD (K844761)Medical Instrument Development Laboratories, Inc.1984-12-24
ORTHOMAG MAGNETIC FORCE SYSTEM (K843550)Medical Magnetics, Inc.1984-12-21
OPTI-LITE (K844351)Innovators, Inc.1984-12-21
ACCESS & 72X ULTRASOUND SCANHEAD UM4 (K843131)Advanced Technology Laboratories, Inc.1984-12-20
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (K842559)Dow Corning Corp. Healthcare Industries Materials1984-12-20
ULTRASOUND 72X & ANNULAR ARRAY SCAN- (K843165)Advanced Technology Laboratories, Inc.1984-12-20
AUTORANGING DIGITAL THERMOMETER (K844273)Micro Idea Instrument Co., Ltd.1984-12-20
INFUSION ASPIRATION VITRECTOMY SYS (K843391)Medical Instrument Development Laboratories, Inc.1984-12-19
MVS XII (K842793)Medical Instrument Development Laboratories, Inc.1984-12-19
SINGLE BASIN SET (K844611)Packaging Technologies, Inc.1984-12-19
PERCUTANEOUS ASPIRATION BIOPSY TRAY (K843885)Applied Medical Devices, Inc.1984-12-19
GENT-L-KARE STERILE I.V. START KIT (K844255)Geneva Laboratories, Inc.1984-12-19
COMPUSTRESS STRESS TESTING SYS (K842339)Intl. Medical, Inc.1984-12-19
CANON 60 DEGREE FUNDUS CAMERA CF-60S (K844053)Canon USA, Inc.1984-12-19
WET PACK (K843783)E.M. Adams1984-12-19
CANON AUTO KERATOMETER K-1 (K844054)Canon USA, Inc.1984-12-19
IV START KIT (K844614)Packaging Technologies, Inc.1984-12-19
UROPAPER EIKEN 7 (K843754)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN G (K843760)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN 5 (K843756)Syn-Kit, Inc.1984-12-18
MICRO-BETA U100 SYRINGE (K844796)Orange Medical Instruments, Inc.1984-12-18
PROVIDER PA 3000 INFUSION SYSTEM (K844078)Pancretec, Inc.1984-12-18
UROPAPER EIKEN GK (K843758)Syn-Kit, Inc.1984-12-18
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY (K843978)Behring Diagnostics, Inc.1984-12-18
UROPAPER EIKEN AG (K843757)Syn-Kit, Inc.1984-12-18
LANDERS-FOULKS TEMP. KERATOPROSTHESIS (K842856)Ocular Instruments, Inc.1984-12-18
UROPAPER EIKEN GP (K843753)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN 6B (K843755)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN HAG (K843759)Syn-Kit, Inc.1984-12-18
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG (K843805)Coulter Electronics, Inc.1984-12-17
ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE (K844557)Ackrad Laboratories1984-12-17
MONOJECT MENGHINI SOFT TISSUE BIOPSY (K843264)Sherwood Medical Co.1984-12-17
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR (K844420)Med-Life, Inc.1984-12-17
SCRUB MATE DRY STERILE SCRUB BRUSH (K844411)American Sterilizer Co.1984-12-17
CT 9000 (K843927)General Electric Co.1984-12-17
CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE (K844015)Cns, Inc.1984-12-17
COROMETRICS FETAL MONITOR 142 (K843918)Ge Medical Systems Information Technologies1984-12-17
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE (K844280)Travenol Laboratories, S.A.1984-12-17
CLOSED URINARY DRAINAGE UNIT (K843698)Pathfinder Intl. Corp.1984-12-17
QCA HEMOGLOBIN KIT (K843695)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-17
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE (K844417)Davis & Geck, Inc.1984-12-17
PRESTILIX 1690 (K843926)Cgr Medical Corp.1984-12-17
ACUTE HEMODIALYSIS TRAYS (K844612)Packaging Technologies, Inc.1984-12-17
TUBING HOLDER (K844757)Procter & Gamble Mfg. Co.1984-12-17
ND3100 VIDEO IMAGER (K843349)Nuclear Data, Inc.1984-12-17
MEDIPART XENON BREATHING KIT MP-02XM (K844495)Medipart Jerry Alexander1984-12-17
VENTIBOX (K844160)Syncor Intl. Corp.1984-12-17
NUCLEAR 700 MEDICINE MECHANICAL POSIT- (K843716)Technicare Corp.1984-12-17
PACE *AID MODEL 52 (K843547)Cardiac Resucitator Corp.1984-12-17
CLAMP, TUBING, LINE (K844121)Dyn-A-Med Products1984-12-17
COUNTERBALANCED VERTICAL CASSETTE HOLDER (K843928)Poersch Metal Mfg. Co.1984-12-17
V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET (K844628)American V. Mueller1984-12-14
SLIP JOINT PLIERS (K844600)Med-Tool, Inc.1984-12-14
CONCEP-7-BHCG (EIA) (K844153)Leeco Diagnostics, Inc.1984-12-14
DIAGONAL PIN CUTTER (K844599)Med-Tool, Inc.1984-12-14
MONTGOMERY SAFE-T-TUBE (K843936)Boston Medical Products, Inc.1984-12-14
API UNISCEPT MIC 100UL (K844159)Analytical Products, Inc.1984-12-14
STAPLE REMOVER SR300P (K833085)Prosper, Inc.1984-12-14
MYOPULSE (K833928)Biomedical Design Instruments1984-12-14
BIPOLAR SUCTION ELECTRODE (K843498)Eder Instrument Co, Inc.1984-12-14
LASERSPEC (K841430)Clement Clarke, Inc.1984-12-13
STERILE PERCUTANEOUS TRANSHEPATIC CHOLAN (K843883)Applied Medical Devices, Inc.1984-12-13
INRA MENEZO B2 MEDIA (K844288)Fcs Laboratories, Inc.1984-12-13
PYRIDOXAL DISC (K844020)Remel Co.1984-12-13
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Track 1984 automatically

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