Atlas FDA

1995

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

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RecordFirmDate
TREBAY TOTAL RECTANGULAR HEAD (K954518)Trebay Medical Corp.1995-10-27
CHEMMATE(TM) UCHL1 (CD45-RO) (K950152)Biotek Solutions, Inc.1995-10-27
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT (K954517)Trebay Medical Corp.1995-10-27
DUNA II PENILE PROSTHESIS (K953640)Dacomed Corp.1995-10-27
EUB-555A+ (K945795)Hitachi Medical Corp. of America1995-10-27
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ (K951373)Fujifilm Medical System U.S.A., Inc.1995-10-27
FORTE ES-400 (K953615)Chattanooga Group, Inc.1995-10-27
4000+ (K950783)U.S. Therapy Products, Inc.1995-10-27
FORTE (K953614)Chattanooga Group, Inc.1995-10-27
B-D SPINAL ANESTHESIA TRAY SPINAL (K953467)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-10-27
JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE (K950869)Jobar Intl., Inc.1995-10-27
ELECTROCARE (K942631)Waco Corp.1995-10-27
EXPLOR-X (AZTEH) HF (K954565)Chicago X-Ray Systems, Inc.1995-10-27
PROTIME MICROCOAGULATION SYSTEM (K951072)International Technidyne Corp.1995-10-27
CHEMMATE(TM) KAPPA (K950150)Biotek Solutions, Inc.1995-10-27
STORZ I/A HANDPIECES (K951463)Storz Instrument Co.1995-10-27
MINISCOPE MS-3 (K954066)Schiller America, Inc.1995-10-27
PROPHET (K953884)Qualitone1995-10-27
UNSCENTED MENSTRAL PAD (K953553)Paragon Trade Brands, Inc.1995-10-27
FEMOSTOP, FEMOSTOP PUMP (K954669)Radi Medical Systems AB1995-10-27
GSI 61 CLINICAL AUDIOMETER (K953684)Grason-Stadler, Inc.1995-10-27
MICRO-PLANER HANDPIECE (K954715)Trebay Medical Corp.1995-10-27
BURGET NASAL STENT (K942025)Bivona Medical Technologies1995-10-27
CRW-1 SYSTEM (K944463)Radionics Software Applications, Inc.1995-10-26
SAS SALMONELLA O GROUP B ANTIGEN (K953848)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA O GROUP A ANTIGEN (K953841)Sa Scientific, Inc.1995-10-26
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET (K945549)Princeton BioMeditech Corp.1995-10-26
A-V IMPULSE SYSTEM MODEL 6060 (K951683)Novamedix , Ltd.1995-10-26
SIMS CPAP SYSTEM (K953485)Smiths Industries Medical Systems, Inc.1995-10-26
SNAP TESTING DEVICE (K944524)Snap Laboratories, LLC1995-10-26
ITP-HVPC GALVANIC STIMULATOR (K943007)Innovative Therapy Products, Inc.1995-10-26
UNSCENTED MENSTRUAL PAD (K953517)Paragon Trade Brands, Inc.1995-10-26
SPETZLER PIN (K954001)Howmedica Corp.1995-10-26
CHEMSTRIP MICRAL URINE TEST STRIPS (K954346)Boehringer Mannheim Corp.1995-10-26
NEEDLELESS INJECTION SITE (K953343)Medical Associates Network, Inc.1995-10-26
COMMANDER MARK II HAIR REMOVAL SYSTEM (K943872)The Helene Edgar Corp.1995-10-26
KENDALL SHERIDAN CPAP SYSTEM (K953511)Kendall Healthcare Products Co. Div.Of Tyco Health1995-10-26
MICROSURGE PUNCTURE CLOSE DEVICE (K954072)Microsurge, Inc.1995-10-26
SAS SALMONELLA O GROUP F ANTIGEN (K953843)Sa Scientific, Inc.1995-10-26
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC (K952361)Princeton BioMeditech Corp.1995-10-26
LASESONICS LOW POWER CO2 LASER SYSTEM (K953917)Heraeus Surgical, Inc.1995-10-26
PODOSPRAY DRILL SYSTEM (K951773)Darco Intl., Inc.1995-10-26
DISPOSABLE FLEX TUBE (K954197)Engstrom Medical1995-10-26
SAS SALMONELLA VI ANTIGEN (K953844)Sa Scientific, Inc.1995-10-26
AXSYM PHENCYCLIDINE II (K953534)Abbott Laboratories1995-10-26
FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC (K954377)Annex Medical, Inc.1995-10-26
THYMATRON 2000 ELECTROCONVULSIVE SYSTEM (K945120)Somatics, Inc.1995-10-26
SAS SALMONELLA O GROUP C ANTIGEN (K953846)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA H C ANTIGEN (K953842)Sa Scientific, Inc.1995-10-26
MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 (K952806)Thomas Industries1995-10-26
COMAN(R) CU-11 MODEL NUMBER 82-6634 (K945585)Johnson & Johnson Professionals, Inc.1995-10-26
WASHER (K953702)Linvatec Corp.1995-10-25
SYNERGY TI ANTERIOR SPINAL SYSTEM (K950709)Cross Medical Products, Inc.1995-10-25
PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP) (K953570)Philips Medical Systems, Inc.1995-10-25
NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES (K953627)New Sun Optical Enterprise Co., Ltd.1995-10-25
AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES (K953744)Amita Corp.1995-10-25
ATH FULL PROFILE ACETABULAR CUP SYSTEM (K954213)Kinamed, Inc.1995-10-25
SINCLAIR NON-PRESCRIPTION SUNGLASSES (K954393)Sinclair Corp.1995-10-25
BLINDE OPTICS (K954636)Blinde Eyewear, Inc.1995-10-25
CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES (K953808)Cheng Chen Hsing Enterp. & Fact. Co. , Ltd.1995-10-25
DRIVING GLASSES (K951757)Proview Optical Group Corp.1995-10-25
ELX808 AUTOMATED MICROPLATE READERS (K953710)Bio-Tek Instruments, Inc.1995-10-25
XKNIFE-3 (K953482)Radionics Software Applications, Inc.1995-10-25
ROCHE REAGENT FOR BUN (K954000)Roche Diagnostic Systems, Inc.1995-10-25
SUNGLASSES (K954639)Walmart Stores1995-10-25
AGEN DIMERTEST GOLD EIA (K945642)Agen Biomedical , Ltd.1995-10-25
PED ALERT (K950656)Orbitec Technologies Corp.1995-10-25
CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY (K945838)Toshiba America Medical Systems, In.C1995-10-25
DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 (K951977)Integrated Display Technology, Ltd.1995-10-24
B-D PEN ULTRA (K951919)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-10-24
CANDELA MODEL PLTL-1 LASER SYSTEM (K953412)Candela Laser Corp.1995-10-24
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG (K953584)Abbott Laboratories1995-10-24
B-FACT, BORDERLINE FACTOR ASSAY CONTROL (K945854)George King Bio-Medical, Inc.1995-10-24
ULTRASOUND PROBE BIOPSY ACCESSORIES (K953430)Biosound, Inc.1995-10-24
CMS URETHRAL WARMER (K952895)Cryomedical Sciences, Inc.1995-10-24
UNIVERSIX 120 (K954196)Philips Medical Systems (Cleveland), Inc.1995-10-24
MAMMOSPOT PADDLE (K954521)American Mammographics, Inc.1995-10-24
HDX DIGITAL IMAGING SYSTEM (K954055)Imacom, Inc.1995-10-24
GUEDEL AIRWAY (K953400)Mallinckrodt Medical1995-10-24
SCINTRON IV (K953193)Medical Imaging Electronics America, Inc.1995-10-24
SIMS BLUE LINE ENDOBRONCHIAL TUBE (K953483)Smiths Industries Medical Systems, Inc.1995-10-24
NUQUEST NUCLEAR MEDICINE COMPUTER (K953255)Sitco, Inc.1995-10-24
MITEK ABSORBABLE ANCHOR (K941599)Mitek Surgical Products, Inc.1995-10-24
PRESSUREGUARD IV (K953503)Span-America Medical Systems, Inc.1995-10-24
A-FACT, ABNORMAL FACTOR ASSAY CONTROL (K945855)George King Bio-Medical, Inc.1995-10-24
HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER (K950004)Aerotel, Ltd.1995-10-24
SIENET SPI SPOOLER (K953552)Siemens Medical Solutions USA, Inc.1995-10-24
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) (K954021)Johnson & Johnson Professionals, Inc.1995-10-24
TYMPANOSTOMY TUBE (K953802)Bluff City Medical Technologies, Inc.1995-10-24
CARPAL TUNNEL SLOTTED CANNULA (K954464)Phx Technologies Corp.1995-10-23
ARTHROPLAST & ARTHRO-CUTTER (K954217)Future Medical Systems, Inc.1995-10-23
VITALOCK SPIKED ACETABULAR SHELL (K953664)Howmedica Corp.1995-10-23
WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES (K954435)Wilo Medizintechnik Lothar Wilberg GmbH1995-10-23
IRIS BILATERAL TMJ (K953248)Hitachi Medical Systems America, Inc.1995-10-23
BOAT NOSE OBTURATOR (K954458)Phx Technologies Corp.1995-10-23
RECLOSABLE WOUND COVER (K954621)Hollister, Inc.1995-10-23
BLUNT DISSECTOR, CURVED (K954475)Phx Technologies Corp.1995-10-23
KSEA REVERSE VIDEO (K952482)KARL STORZ Endoscopy-America, Inc.1995-10-23
TRIGLYCERIDES REAGENT (K954187)Schiapparelli Biosystems, Inc.1995-10-23
NIOMED NON-SKID SHOE COVERS (K952937)Amerasia Corp.1995-10-23
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Track 1995 automatically

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