Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SYNERMED SERUM IRON-600 REAGENT KIT (K912912)Synermed, Inc.1991-07-30
PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE (K912194)Jelenko Co.1991-07-30
GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. (K911989)Somnitec, Inc.1991-07-30
SOFTTOUCH(R) GUIDING CATHETER (K912199)Mallinckrodt Medical1991-07-30
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT (K911302)Medtronic Vascular1991-07-30
ALTA CHANNEL PLATE CONNECTOR (K910482)Howmedica Corp.1991-07-30
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221 (K912084)Medtronic Vascular1991-07-30
IONOSEAL (K912495)Voco GmbH1991-07-30
POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF (K912076)The R Group1991-07-30
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 (K912808)Em Diagnostic Systems, Inc.1991-07-30
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121 (K912465)Med Institute, Inc.1991-07-30
CYTOCLONE A & B EIA (K911958)Cambridge Biotech Corp.1991-07-30
VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110 (K912424)Med Institute, Inc.1991-07-30
STRYKER ECLIPSE WARMING STRETCHER (K912237)Stryker Medical1991-07-30
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 (K912810)Em Diagnostic Systems, Inc.1991-07-30
IONOBOND (K912497)Voco GmbH1991-07-30
MECONIUM ASPIRATION (K912596)Pacific Device, Inc.1991-07-30
QSI 9500 (K904294)Quantified Signal Imaging, Inc.1991-07-30
MEDIKEEPER (K912346)Medikeeper, Inc.1991-07-30
BACTI-SWAB(TM) II (K912831)Remel Co.1991-07-30
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP (K910608)Biotronik, GmbH & Co.1991-07-30
MEDI-THERM (MTA-5900) & DETACHABLE HOSES (K912051)Gaymar Industries, Inc.1991-07-30
VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112 (K912423)Med Institute, Inc.1991-07-30
CHOLESTECH LIPID MONITORING SYS. (K912136)Cholestech Corp.1991-07-30
SALTER LABS INFANT NASAL CPAP CANNULA (K912434)Salter Labs1991-07-30
DISTAT ANTI-SCL-70 KIT (K912291)Shield Diagnostics, Ltd.1991-07-30
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (K912725)Creative Laboratory Products, Inc.1991-07-30
DIASTAT ANTI-JO-1 KIT (K912292)Shield Diagnostics, Ltd.1991-07-30
K-FREE (K912587)Katecho, Inc.1991-07-30
REP ALP-15, 8, & 4 KITS (K912603)Helena Laboratories1991-07-30
LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (K912858)London Diagnostics, Inc.1991-07-30
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS (K913066)Syva Co.1991-07-30
507 NON-INVASIVE VITAL SIGNS MONITOR (K910852)Criticare Systems, Inc.1991-07-30
SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP (K912191)Mallinckrodt Medical1991-07-30
MILENIA ESTRADIOL (K912917)Diagnostic Products Corp.1991-07-30
KITS AND TRAYS FOR ONE TIME USE ONLY (K903963)Apk Technology1991-07-29
INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (K903962)Apk Technology1991-07-29
BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200 (K911922)Delta Industries, Inc.1991-07-29
MICROTRAK MANAGER (K912959)Syva Co.1991-07-26
INTAVENT LARYNGEAL MASK (K904834)Intavent Intl. S.A.1991-07-26
ARTEMA AQUA+ FLEX (K912336)Artema Medical AB1991-07-26
THE VOSS DISPOSABLE SUCTION/IRRIGATION CANNULA (K912579)Voss Products1991-07-26
CEDIA(R) TOBRAMYCIN ASSAY (K912143)Microgenics Corp.1991-07-26
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST (K913024)Em Diagnostic Systems, Inc.1991-07-26
SHUR-GRIP (K912834)Inman Medical Corp.1991-07-26
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (K912756)Roche Diagnostic Systems, Inc.1991-07-26
MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE (K911901)Stortz1991-07-26
ECONOVAGE R (K911788)Autovage1991-07-26
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS (K912757)Roche Diagnostic Systems, Inc.1991-07-26
FINN KNEE PROSTHESIS (K910877)Biomet, Inc.1991-07-26
ARTEMA AQUA+ (K912333)Artema Medical AB1991-07-26
ROBOTIC SAMPLE PROCESSOR (K912036)Tecan U.S., Ltd.1991-07-26
SYSMEX F-310 (K911173)Toa Medical Electronics USA, Inc.1991-07-26
ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (K903175)Advance Suture, Inc.1991-07-26
MINIVAGE(R) (K911919)Autovage1991-07-26
OSTEONICS(R) PRT HIP STEM SERIES (K911890)Osteonics Corp.1991-07-26
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX (K912520)3M Health Care, Ltd.1991-07-26
ABUSCREEN ONLINE FOR AMPHETAMINES (K912758)Roche Diagnostic Systems, Inc.1991-07-26
SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 (K911154)Sun Medical, Inc.1991-07-26
ULTIMATE 3000 (K910839)Fonar Corp.1991-07-26
COX DIAPOSABLE POLYPECTOMY SNARE (K912254)Cox Medical Ent., Inc.1991-07-26
URETERAL CATHETER HOLDER (K912146)Inman Liebelt Corp.1991-07-26
MASTERPIECES MICRO SYSTEM (K910957)Storz Instrument Co.1991-07-26
SOMNIMIC (R) (K912817)Somnitec, Inc.1991-07-26
ARTEMA AQUA+ T & TS (K912334)Artema Medical AB1991-07-26
PERRYMETER(TM) (K911190)Perrymeter Systems1991-07-26
PRECISION OPTICS CORPORATION LAPAROSCOPE (K911744)Precise Optics1991-07-26
MULTICHANNEL RECORDING SYSTEM (K912427)Bionique1991-07-26
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS (K912048)Roche Diagnostic Systems, Inc.1991-07-26
SYSMEX F-610 (K911172)Toa Medical Electronics USA, Inc.1991-07-26
GROSS HIP FEMORAL COMPONENT (K904737)Johnson & Johnson Orthopaedics, Inc.1991-07-26
FORCEPS (K904723)Minto Research & Development, Inc.1991-07-26
INSUL-LINE (K911443)Trademark Corp.1991-07-26
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (K912826)Cala Diagnostics1991-07-26
MODELS UES-10 & PSD-10 (K911904)Olympus Corp.1991-07-26
ARTEMA AQUA+ N (K912335)Artema Medical AB1991-07-26
MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED (K912980)Dexide, Inc.1991-07-26
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE (K912545)Pace Medical1991-07-26
THE NEEDLE NABBER (K911597)J. Simmons Instrument , Ltd.1991-07-26
BONE NAIL, KUNTSCHER (K911982)International Hospital Supply Co.1991-07-26
PLASTIC OVERLAYS (K911374)National Reading Service1991-07-26
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (K910304)Vitek Systems, Inc.1991-07-26
SYSMEX F-810 (K910849)Toa Medical Electronics USA, Inc.1991-07-26
MAGNESIUM ASSAY KIT, CAT.# 100-12 (K912825)Diagnostic Chemicals, Ltd. (Usa)1991-07-26
MAJOLI UTERINE MANIPULATOR/INJECTOR (K911887)Cook Ob/Gyn1991-07-26
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM (K911998)Allergan Medical Optics1991-07-26
OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER (K912522)Summit Technology, Inc.1991-07-25
SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS (K912004)Shepherd Medical Products, Inc.1991-07-25
TBD, LENS MEASURING DEVICE (K912134)Alcon Laboratories1991-07-25
BLOOD PRESSURE CUFFS (K912638)Vital Signs, Inc.1991-07-25
DIMAC WIRES (K910090)Instrumentations Unltd.1991-07-25
WYMAN SUTURE WASHER (K910186)Acu Med, Inc.1991-07-25
LANDERS THREE STRUT VITRECTOMY LENS RING (K912151)Ocular Instruments, Inc.1991-07-25
NARKOMED AV-E VENTILATOR (K912533)Draeger Medical, Inc.1991-07-25
GATES GLIDDEN DRILLS (K905418)The Hygenic Corp.1991-07-25
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC (K912485)Coltene/Whaledent, Inc.1991-07-25
KALLESTEAD TOTAL IGE MICROPLATE KIT (K912800)Bio-Rad Laboratories, Inc.1991-07-25
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (K912318)Serono-Baker Diagnostics, Inc.1991-07-25
RT40 RADIO TRANSLUCENT (K912714)Bio-Detek, Inc.1991-07-25
LAPAROSCOPIC LASER FIBER DIVERTER (K912502)United States Endoscopy Group, Inc.1991-07-25
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Every clearance here is in the API, with alerts when new ones post.