Atlas FDA

1991

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

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RecordFirmDate
REAL TIME X-RAY IMAGING SYSTEM (K911082)Siemens Medical Solutions USA, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III (K911171)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II (K911177)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I (K911176)Analytical Control Systems, Inc.1991-05-01
UNI-SEM(TM) (K910317)Unimar, Inc.1991-05-01
SERIM PERACETIC ACID REAGENT STRIPS (K910320)Serim Research Corp.1991-05-01
SLEEPER MASK SYSTEM (K904344)Devilbiss Health Care, Inc.1991-05-01
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER (K910432)Lifecore Biomedical, Inc.1991-05-01
CIBA CORNING ACS FT4 IMMUNOASSAY (K910684)Ciba Corning Diagnostics Corp.1991-05-01
MSTIM-2000 EMS (K904332)Oms Medical Supplies, Inc.1991-05-01
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II (K911170)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 (K910930)Analytical Control Systems, Inc.1991-05-01
SCHNEIDER WALLSTENT(R) (K911292)Pfizer Hospital Products Group, Inc.1991-05-01
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE (K903345)C.R. Bard, Inc.1991-04-30
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER (K905704)Maico Hearing Instruments, Inc.1991-04-30
ARGIPLUS (K910467)Argen Precious Metals, Inc.1991-04-30
AMYLASE (K910158)Pointe Scientific, Inc.,1991-04-30
CIBA CORNING ACS TSH IMMUNOASSAY (K910981)Ciba Corning Diagnostics Corp.1991-04-30
HT4-SERIES HYSTEROSCOPES AND ACCESSORIES (K905392)Frigitronics, Inc.1991-04-30
DR. DEDO'S FAMILY EAR EXAMINATION KIT (K904659)Panex Corp.1991-04-30
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL (K905702)Dentsply Intl.1991-04-29
BRONCHOSCOPE BF-N20 (K910423)Olympus Corp.1991-04-29
V-SUPER (K911532)Metalor Dental USA Corp.1991-04-29
UST-974-5 CONVEX TRANSDUCER (K911309)Ge Medical Systems Information Technologies1991-04-29
PROTH-AURO 22 (K911540)Metalor Dental USA Corp.1991-04-29
NORLAND XR26 WHOLE BODY OPTION (K901804)Norland Corp.1991-04-29
VS-200S JET VENTILATOR (K900745)Acutronic Medical Systems AG1991-04-29
SOLARO 3 (K911543)Metalor Dental USA Corp.1991-04-29
ARTHROBOT(TM) WRIST HOLDER ACCESSORY (K911522)Andronic Devices, Ltd.1991-04-29
VESSEL DILATORS (K910502)Akcess Medical Products, Inc.1991-04-29
PIGGY LOCK NEEDLE HOUSING (K910546)Icu Medical, Inc.1991-04-29
INTERSPEC APOGEE, MODIFICATION (K910049)Interspec, Inc.1991-04-29
LAPAROSCOPIC SNARE POUCH (K911478)United States Endoscopy Group, Inc.1991-04-29
SILICOATER MD (K910719)Kulzer, Inc.1991-04-29
HEPARIN CONTROLS, HIGH AND LOW (K910741)Sigma Diagnostics, Inc.1991-04-29
PONTOR 4 CF (K911541)Metalor Dental USA Corp.1991-04-29
INJECTION CAPS (K910572)Akcess Medical Products, Inc.1991-04-29
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST (K905787)Vitek Systems, Inc.1991-04-29
MULTILAB 2000 (K904392)Unetixs, Inc.1991-04-29
BARRIER* EXTRA PROTECTION PLUS FACE MASK (K910557)Johnson & Johnson Medical, Inc.1991-04-29
V-DELTA, SF (K911537)Metalor Dental USA Corp.1991-04-29
PONTOR 2 (K911542)Metalor Dental USA Corp.1991-04-29
V-DELTABOND (K911536)Metalor Dental USA Corp.1991-04-29
SOLARO 4 (K911544)Metalor Dental USA Corp.1991-04-29
LAPAROSCOPIC IRRIGATOR/ASPIRATOR (K910209)Solos Mfg.1991-04-29
BC 1208 IMPLANT, THREADED EXTERNAL HEX (K904707)Minimatic Implant Technology1991-04-29
OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12 (K900880)Olympus Corp.1991-04-29
POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND (K905582)Milton Hodosh, M.D.1991-04-29
AUROFLUID 3 (K911539)Metalor Dental USA Corp.1991-04-29
PERMANENT SILICONE CATHETERS (K910501)Akcess Medical Products, Inc.1991-04-29
AMS 3000 PORTABLE JET VENTILATOR (K900744)Acutronic Medical Systems AG1991-04-29
V92 (K911533)Metalor Dental USA Corp.1991-04-29
S5192R TRANSDUCER (K904951)Acuson Corp.1991-04-29
INSULATED HOOK SCISSORS/J & L HOOK KNIVES/SPATULA (K911316)Northgate Technologies, Inc.1991-04-29
IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER (K905039)Minimatic Implant Technology1991-04-29
V44 (K911534)Metalor Dental USA Corp.1991-04-29
AUROFLUID 2 (K911538)Metalor Dental USA Corp.1991-04-29
ORTHODONTIC BONDING ADHESIVE CONTROL (K904090)Lancer Orthodontics, Inc.1991-04-29
J&S PEDIATRIC IRON SATURATING REAGENT (K910672)J.S. Medical Assoc.1991-04-29
DISPOSAL PAD FOR SHARPS (K910516)Visitec Co.1991-04-29
RUBENOSTIKA IGG MICROELISA SYSTEM (K911393)Organon Teknika Corp.1991-04-29
CORE DISPOSABLE SUCTION/IRRIGATION TUBING (K910246)Core Dynamics, Inc.1991-04-29
IMMULITE(TM) T-UPTAKE (K910677)Cirrus Diagnostics, Inc.1991-04-29
V-GNATHOS (K911530)Metalor Dental USA Corp.1991-04-29
V-CLASSIC (K911535)Metalor Dental USA Corp.1991-04-29
CIBA CORNING ACS T UPTAKE IMMUNOASSAY (K911093)Ciba Corning Diagnostics Corp.1991-04-29
LAPAROSCOPIC INSUFLATION Y TUBING (K911479)United States Endoscopy Group, Inc.1991-04-29
INTRODUCER NEEDLES (K910641)Akcess Medical Products, Inc.1991-04-29
ALL-BOND 2 (K910860)Bisco, Inc.1991-04-29
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR (K905495)Frigitronics, Inc.1991-04-29
V-SUPERGOLD (K911531)Metalor Dental USA Corp.1991-04-29
ABS CADKIT (K910636)Panbio, Inc.1991-04-29
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE (K910973)Surgical Technologies, Inc.1991-04-26
ELECTROSONOGRAM ESG-1 (K905449)Myo-Tronics, Inc.1991-04-26
TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE (K904943)Arzco Medical Electronics, Inc.1991-04-26
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION (K905520)Synectics-Dantec1991-04-26
SERVO VENTILATOR 300 (K902859)Siemens Life Support Systems1991-04-26
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A (K910490)Hewlett-Packard Co.1991-04-26
SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2 (K910597)Radix Group Intl.1991-04-26
INTIMAX THROMBECTOMY CATHETER (K910372)Applied Vascular Devices, Inc.1991-04-26
ARRHYTHMIA 9215 (K900366)S & W Medico Teknik1991-04-26
COMPAC(TM) DIODE LASERS (K904699)Hgm Medical Laser Systems, Inc.1991-04-25
KENDALL PEDIATRIC URINE METER (K911258)Kendall Healthcare Products Co. Div.Of Tyco Health1991-04-25
PHARM-ASSIST (K905116)Excel Medical, Inc.1991-04-25
WILSON-COOK DISPOSABLE BIOPSY FORCEPS (K910656)Wilson-Cook Medical, Inc.1991-04-25
ENDOSCOPE AND ACCESSORIES (K905117)Northgate Technologies, Inc.1991-04-25
STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE (K911189)Internacional Farmaceutica, S.A. DE C.V.1991-04-25
SURGICAL GOWNS, EXTRA-LARGE SIZE (K910410)Dawn of Hope Development Center1991-04-25
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER (K911242)Kendall Healthcare Products Co. Div.Of Tyco Health1991-04-25
TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM (K911101)Zofcom, Inc.1991-04-25
SPLASH GUARD (K905173)E.M. Adams1991-04-25
CONSUMER SENSORY PRODUCTS BIO-LOG 8000 (K904955)Consumer Sensory Products, Inc.1991-04-25
DISPOSABLE ELECTROSURGICAL BLADE (K910779)Conmedcorp1991-04-25
EUDERMIC SURGICAL GLOVES (K911245)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-04-25
SURGITRON (K911461)Ellman Intl. Mfg., Inc.1991-04-25
LAPAROSCOPIC SUCTION/IRRIGATION CANNULA (K911486)United States Endoscopy Group, Inc.1991-04-25
PATIENT EXAMINATION LATEX GLOVES (NON-STERILE) (K911694)Guthrie Medicare Products (Melaka) Sdn Bhd1991-04-25
LAPAROSCOPIC IRRIGATION PUMP (K911493)United States Endoscopy Group, Inc.1991-04-25
BARD 3000 PLUS URETEROSCOPY SYSTEM (K911411)C.R. Bard, Inc.1991-04-25
PLASTIC (VINYL) EXAMINATION GLOVES (K910879)Siamount Plastic Corporation , Ltd.1991-04-25
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Every clearance here is in the API, with alerts when new ones post.