Atlas FDA

1991

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

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RecordFirmDate
SORBSAN TOPICAL WOUND DRESSING (MODIFIED) (K914575)Dow B. Hickam, Inc.1991-12-04
ESPE(R) -SIL (K913965)Espe GmbH (Us)1991-12-04
GAUZE BANDAGE ROLL (K914842)Cal West Trading Co.1991-12-04
GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE (K914449)W. L. Gore & Associates, Inc.1991-12-04
ETHICON ABSORBABLE SUTURE CLIP AND APPLIER (K914549)ETHICON, Inc.1991-12-04
ALGINATE FIBER (K914779)Adri/Technam1991-12-04
DIAZO COLORIMETRY, BILIRUBIN (K914873)Pointe Scientific, Inc.,1991-12-04
FACSTRAK FLOW CYTOMETER (K914014)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-12-04
2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) (K914114)Resonex, Inc.1991-12-04
STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES (K914937)Kerma Medical Products, Inc.1991-12-04
CAVOMAT (K911388)Wiest USA, Inc.1991-12-04
GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE (K914000)Depuy, Inc.1991-12-04
STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT (K913185)Internacional Farmaceutica, S.A. DE C.V.1991-12-04
TYPE 9210 S/ECG (K903940)S & W Medico Teknik1991-12-04
DROLITE(TM) LIGHT SOURCE (K913273)Vision Medical, Inc.1991-12-04
OPHTHALMIC STAND (K913961)Luneau Ophtalmologie SA1991-12-04
SECURODRIP (K912660)Op-Co Medical Products , Ltd.1991-12-04
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 (K912188)Critikon Company, LLC1991-12-04
EVACU SLED (K913520)Nexus Health Care Products , Ltd.1991-12-04
WOMEN AND INFANT'S DELIVERY PACK (K912869)Welcon, Inc.1991-12-04
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION (K914971)Nihon Kohden America, Inc.1991-12-04
WEHRS INCUS AND INCUS-STAPES PROSTHESES (K910685)Smith & Nephew Richards, Inc.1991-12-04
ABSORBENT FIBER (K914431)Ulti-Med Intl., Inc.1991-12-04
IL TEST(TM) COCAINE (K913737)Instrumentation Laboratory CO1991-12-03
IMPERVA DUAL (K913946)Shofu Dental Corp.1991-12-03
KODAK MIN-R IDENTIFICATION CAMERA (K915088)Eastman Kodak Company1991-12-02
SI-450/ILUS (INTRALUMINAL ULTRASOUND) (K912361)Siemens Ultrasound, Inc.1991-12-02
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (K914944)Bennett X-Ray Corp.1991-12-02
SIEMENS SI-400 (K914013)Siemens Ultrasound, Inc.1991-12-02
FRUCTOSAMINE ABG21 TEST SYSTEM (K913614)Boehringer Mannheim Corp.1991-12-02
OPTIFIBER (K914423)Minimal Invasive Therapy and Diagnostics, Inc.1991-12-02
LUHR PAN FIXATION SYSTEM (K913355)Howmedica Corp.1991-12-02
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM (K914328)Siemens Medical Solutions USA, Inc.1991-12-02
HUMAN IGD IMMUNOLOGICAL NL TEST KIT (K913671)The Binding Site, Ltd.1991-12-02
QUALTEX MAGNETIC INSTRUMENT DRAPE (K914369)Deroyal Industries, Inc.1991-12-02
URODYNAMIC RECTAL BALLOON (K912451)Cook Urological, Inc.1991-12-02
REPEL(TM) LITE CUT RESISTANT GLOVE LINERS (K914077)Depuy-Raynham1991-12-02
ATRIUM DUAL ATS WATER SEAL CHEST DRAIN UNIT (K912956)Atrium Medical Corp.1991-11-29
BIRD NEBULIZATION SYNCHRONIZER (K911336)Bird Products Corp.1991-11-29
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION (K913955)Northgate Technologies, Inc.1991-11-29
MICRO EIA FOR MARIJUANA METABOLITES (K914490)Microdiagnostics, Inc.1991-11-29
KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE (K913413)Sherwood Medical Co.1991-11-29
I.V. FILTER EXTENSION SET (K912848)Filtertek, Inc.1991-11-29
ABBOTT MATRIX AERO PLUS SYSTEM (K913150)Abbott Laboratories1991-11-29
PB100 DIAGNOSTIC SPIROMETER (K911143)Puritan Bennett Corp.1991-11-29
MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN (K913463)Bruker Medical Imaging, Inc.1991-11-29
DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER (K911883)Diag Corp.1991-11-29
EPO-RIA (K910481)Ramco Laboratories, Inc.1991-11-29
STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL (K914560)Ppg Industries, Inc.1991-11-29
INFRARED HEAT LAMP MODEL NH-202 (K913880)National Health-Care Equipment, Inc.1991-11-29
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) (K915003)Syva Co.1991-11-29
INFRARED HEAT LAMPS & MASSAGER MODEL NH-213 (K913973)National Health-Care Equipment, Inc.1991-11-29
ABBOTT IMX TOXO IGM POSITIVE CONTROL (K913106)Abbott Laboratories1991-11-29
INFRARED HEAT LAMP MODEL NH-201 (K913856)National Health-Care Equipment, Inc.1991-11-29
IL TEST(TM DIGOXIN (K914151)Instrumentation Laboratory CO1991-11-29
SNAPPER (K913608)Healthtek, Inc.1991-11-29
PNEUMO-SEAL(TM) (K914470)Edward Weck, Inc.1991-11-29
HYDRODISECTOR (K914177)Spiess Design, Inc.1991-11-29
ANGLED BLADE PLATE (K914546)Synthes (Usa)1991-11-29
MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955 (K912610)Atrium Medical Corp.1991-11-29
MINI-OP ATS BLOOD RECOVERY BAG, MOEL 2950 (K912609)Atrium Medical Corp.1991-11-29
C-150 ULTRAFAST CT SCANNER (K913352)Imatron, Inc.1991-11-29
SYVA EMIT D.A.U. COCAINE METABOLITE (K914973)Syva Co.1991-11-29
SWEDE CROSS MANUAL WHEELCHAIR (K914610)Etac Us, Inc.1991-11-29
WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY (K914277)Schneider U.S. Stent Div.1991-11-29
MAXIMA-10 (K911206)Stirn Industries1991-11-29
CONNECTING SET (K914128)Procedure Products, Inc.1991-11-27
MODEL 311GE-64: WHOLE VOLUME NECK COIL (K914535)Medical Advances, Inc.1991-11-27
3M ANTI-CARDIOLIPIN FAST(TM) TEST (K913054)3M Diagnostic Systems, Inc.1991-11-27
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE (K913879)R&D Systems, Inc.1991-11-27
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (K914511)Technicon Instruments Corp.1991-11-27
ACS ULTRA-2 THROMBOPLASTIN (K913250)Analytical Control Systems, Inc.1991-11-27
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS (K912641)Biopro, Inc.1991-11-27
FVP-1000 FAMILY AND FVP-1000D FAMILY (K905694)Fischer Imaging Corp.1991-11-27
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT (K914906)Bio-Tek Instruments, Inc.1991-11-27
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM (K913929)Ophthalmic Imaging Systems1991-11-27
CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC (K914296)Nuccardiac Software, Inc.1991-11-27
ENDO I/A Y SET (K913979)Snowden-Pencer1991-11-27
DIMENSION(R) LACTIC ACID METHOD (K914508)E.I. Dupont DE Nemours & Co., Inc.1991-11-27
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID (K914981)Beltone Electronics Corp.1991-11-27
REP(R) SPE TEMPLATE 30, 16, & 8 (K913807)Helena Laboratories1991-11-27
REFURBISHED ORTHODONTIC APPLIANCES (K913913)Ortho-Cycle Co.1991-11-27
SUAN FLAT DISSECTOR SPONGES (K914082)Icn Pharmaceuticals, Inc.1991-11-27
COULTER CARBON DIOXIDE REAGENT (K914486)Coulter Corp.1991-11-27
MICRO-X 30 HF (K914266)Fischer Imaging Corp.1991-11-27
TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (K914888)Technicon Instruments Corp.1991-11-27
RECIRCULATION KIT #7-510-18 (K914402)Northgate Technologies, Inc.1991-11-27
GENERAL USE KIT #7-510-20 (K914403)Northgate Technologies, Inc.1991-11-27
MRT-150A (K914012)Toshiba America Mri, Inc.1991-11-27
MICRO-X 50 HF (K914236)Fischer Imaging Corp.1991-11-27
ECAT SCANNER (MODEL 921) (K913637)Cti Pet Systems, Inc.1991-11-27
ACE CORTICAL BONE SCREW (K912598)Ace Medical Co.1991-11-27
MODELS 190GE-64/191GE-64/192GE-64/193GE-64 (K914536)Medical Advances, Inc.1991-11-27
BELTONE PROFILE IN-THE-EAR HEARING AID (K914982)Beltone Electronics Corp.1991-11-27
POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES (K914498)Medmark, Inc.1991-11-27
MX927 BLOOD TRANSFER DEVICE (K913498)Medex, Inc.1991-11-27
P2020-8-0 BEAM-LIMITING DEVICE (K914184)Precise Optics1991-11-27
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (K910991)Shiley, Inc.1991-11-27
DRILL MODULES MODELS 2116/2117 (K914346)Micro Surgical Instruments Corp.1991-11-27
ENDOSSEOUS IMPLANTS (K904236)Attachments Intl., Inc.1991-11-27
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Every clearance here is in the API, with alerts when new ones post.