Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ACCU-BEAM 300W XENON LIGHT SOURCE (K951895)Tti Medical1995-05-24
4000 AU ULTRASOUND IMAGING SYSTEM (K944485)Biosound, Inc.1995-05-24
COLTOLUX 3, COLTOLUX 4 (K945698)Coltene/Whaledent, Inc.1995-05-24
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN (K926496)Sil-Med Corp.1995-05-24
FLUOREX DTA-400A (K946081)Toshiba America Medical Systems, In.C1995-05-24
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) (K950687)Belmont Instrument Corp.1995-05-24
FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L (K950721)Fujifilm Medical System U.S.A., Inc.1995-05-24
PERMAQUIK BONDING PRIMER (K951867)Ultradent Products, Inc.1995-05-23
ORTHODONITC ELASTOMERIC SLEEVING (K943421)Jon-Ko Products, Inc.1995-05-23
THE STACHROM HEPARIN ASSAY KIT (K925433)American Bioproducts Co.1995-05-23
OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES (K945267)Optus, Inc.1995-05-23
ORTHODONTIC ELASTOMERIC CHAIN (K943420)Jon-Ko Products, Inc.1995-05-23
BAND SEATER (K951776)Ormco Corp.1995-05-23
TC 3000 (K942881)Gaymar Industries, Inc.1995-05-23
CEREC 2 (K950299)Pelton & Crane Co.1995-05-23
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR (K950629)Bio-Rad Laboratories, Inc.1995-05-23
RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE (K935842)Rusch, Inc.1995-05-23
CATCO THORACIC CATHETER (K945728)Catco Medical, Inc.1995-05-23
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR (K950284)Sims Deltec, Inc.1995-05-23
SAFE-TIPS EZ (K951238)Safe Wave Products, Inc.1995-05-23
FUJI IX (K951555)GC America, Inc.1995-05-23
LIFECARE 175 INFUSER, MODIFICATION (K944190)Abbott Laboratories1995-05-23
TRIADYNE (K944094)Kinetic Concepts, Inc.1995-05-23
PRIME & BOND DIRECT COMPOSITE BONDING AGENT (K951864)Dentsply Intl.1995-05-23
E-PACK PROCEDURE KITS (K951476)ETHICON, Inc.1995-05-23
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (K943418)Jon-Ko Products, Inc.1995-05-23
CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM (K946165)Elekta Instruments, Inc.1995-05-23
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011 (K940179)Richard Wolf Medical Instruments Corp.1995-05-23
CMT-1000 (K942428)Ems, Inc.1995-05-23
ALTRA FLUX(TM) 170 HEMODIALYZER (K945542)Althin Medical AB an Affiliate of Baxter Intl1995-05-23
EXTENTION SET (K933524)Mediziv Medical Products 1987 , Ltd.1995-05-23
PRECISION BIPOLAR COAGULATOR (K951985)Valley Forge Scientific Corp.1995-05-23
MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER (K951515)Sherwood Medical Co.1995-05-23
CONAIR BODY AND SOLE (K950410)Conair Corp.1995-05-23
ORTHODONTIC ELASTOMERIC TUBE/THREAD (K943417)Jon-Ko Products, Inc.1995-05-23
PROSTAT CONTROL (K943394)Quantimetrix Corp.1995-05-23
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K952014)Prima, Inc.1995-05-22
PRIMA VENTILATOR HOSES (K952010)Prima, Inc.1995-05-22
NATURAL-KNEE II SYSTEM (K936159)Intermedics Orthopedics1995-05-22
PRIMA GUEDEL AIRWAYS (K952013)Prima, Inc.1995-05-22
ENDOTRACHEAL TUBE (K951696)Unomedical Sdn Bhd1995-05-22
POSTERIOR CAPSULE SHIELD (K950798)Oasis Medical, Inc.1995-05-22
PRIMA ADULT GAS SAMPLING CIRCUITS (K952019)Prima, Inc.1995-05-22
PRIMA COAXIAL CIRCUITS (K952018)Prima, Inc.1995-05-22
HEMI-SHOULDER PROSTHESIS (K950594)Encore Orthopedics, Inc.1995-05-22
SELECT(R) SHOULDER ALL POLY GLENOID (K935802)Intermedics Orthopedics1995-05-22
INSALL-BURSTEIN II (K935080)Hospital For Special Surgery1995-05-22
FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND (K931265)Ferguson Medical1995-05-22
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483)Hewlett-Packard Co.1995-05-22
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR (K950384)Synthes (Usa)1995-05-22
PRIMA VOLUMN VENTILATORSS (K952022)Prima, Inc.1995-05-22
MITEK TOGGLE ANCHOR(TM) (K950070)Mitek Surgical Products, Inc.1995-05-22
PRO-PAK FOR OMS DIPLOMATE (K950800)M. Imonti and Associates Inc.,1995-05-22
PEDIATRIC ENDOTRACHEAL TUBE (K951697)Unomedical Sdn Bhd1995-05-22
NIHON KOHDEN ELECTROENCEPHALOGRAPH (K944678)Nihon Kohden America, Inc.1995-05-22
PRIMA HYUPERINFLATION SYSTEM (K952021)Prima, Inc.1995-05-22
FNA BIOPSY NEEDLE (K941722)Betta Medical, Inc.1995-05-22
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (K952016)Prima, Inc.1995-05-22
NOBLES-LAI VIDEO IMAGING SYSTEM (K940273)Visioneering, Inc.1995-05-22
PRIMA MAPLESON D CIRCUIT (K952017)Prima, Inc.1995-05-22
PRIMA CUSTOM ANESTESIA CIRCUIT (K952012)Prima, Inc.1995-05-22
PRIMA BREATHING BAGS (K952011)Prima, Inc.1995-05-22
PRIMA PEDIATRIC ANESTHESIA CIRCUITS (K952020)Prima, Inc.1995-05-22
PROFORM CEMENTED FEMORAL COMPONENT (K951083)Stelkast Company1995-05-22
PRIMA FILTER (K952015)Prima, Inc.1995-05-22
SCIMED(R) VENTURE(TM) II INFUSION CATHETER (K945904)Scimed Peripheral Interventions1995-05-19
SYNTHETIC ABSORBABLE SUTURE (K944937)Johnson & Johnson International1995-05-19
HEMOLAB COFAC IX (K942050)Biomerieux Vitek, Inc.1995-05-19
BIOMERIEUX HEMOLAB COFAC II (K942049)Biomerieux Vitek, Inc.1995-05-19
CARDIOVIT AT-5C (K941462)Schiller America, Inc.1995-05-19
I.V. FILTER SET (K933523)Mediziv Medical Products 1987 , Ltd.1995-05-19
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP) (K950852)H.S. Intl. Co., Inc.1995-05-19
HEMAGEN CHAGAS' KIT (EIA METHOD) (K930272)Hemagen Diagnostics, Inc.1995-05-19
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K952009)Prima, Inc.1995-05-19
STERRAD STERILIZATION POUCH (K951295)Advanced Sterilization Products1995-05-19
TIBIA-TALUS-CALCANEUS NAIL (K950394)Smith & Nephew Richards, Inc.1995-05-19
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (K951064)S-E Sales & Distribution, Inc.1995-05-19
PHOTOTHERAPEUTIX MODEL 2480AB (K935525)Avex Industries , Ltd.1995-05-19
AT33 EMG (K930578)Autoject Systems, Inc.1995-05-19
ACCUTEST (K940615)Instrumed, Inc.1995-05-19
QUICKVUE(R) CHLAMYDIA TEST (K946276)Quidel Corp.1995-05-19
STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM (K951874)Strato/Infusaid, Inc.1995-05-19
LF CT HIG PRESSURE CATHETERS (K945053)Mallinckrodt Group, Inc.1995-05-19
STERILE EMPTY PCA SYRINGE (K945797)Intl. Medication Systems, Ltd.1995-05-19
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 (K945065)Sorin Biomedical, Inc.1995-05-19
FILTRYZER(TM) (K935471)Toray Industries (America), Inc.1995-05-19
STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM (K951873)Strato/Infusaid, Inc.1995-05-19
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807)Bio-Rad Laboratories, Inc.1995-05-19
AT64 SCR (K930577)Autoject Systems, Inc.1995-05-18
LATEX CONDOMS W/SPERMICIDAL LUBRICANT (NONOXYNOL-9) (K942858)Suretex, Ltd.1995-05-18
155 SCE(TM) HEMODIALYZER (K945631)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
AXSYM BARBITURATES II U (K951253)Abbott Laboratories1995-05-18
MEDICAL SUPPORT STOCKINGS (K951234)Jobst A Beiersdorf Co.1995-05-18
STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM (K951872)Strato/Infusaid, Inc.1995-05-18
75K STAIGHT DRILL (K943541)Stryker Corp.1995-05-18
MCA(TM) 130 HEMODIALYZER (K945623)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
ALTRA FLUX(TM) 140 HEMODIALYZER (K945620)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
RIB RESECTOR (K951492)United States Surgical, A Division of Tyco Healthc1995-05-18
MCA(TM) 160 HEMODIALYZER (K945624)Althin Medical AB an Affiliate of Baxter Intl1995-05-18
AT42 (K930576)Autoject Systems, Inc.1995-05-18
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Every clearance here is in the API, with alerts when new ones post.