Atlas FDA

1995

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

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856)Zoll Medical Corp1995-12-29
PYRILINKS-D ASSAY KIT (K952320)Metra Biosystems, Inc.1995-12-29
CONDENSATE COLLECTION KIT (K954480)Nova-Ventrx1995-12-29
BTE CPM-20 (K955106)Baltimore Therapeutic Equipment Co.1995-12-29
LIFEPAK 11 (K951593)Physio-Control Corp.1995-12-29
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY (K955390)Corning Nichols Diagnostics1995-12-29
AUTOMATED TRU-CUT BIOPSY DEVICE (K954529)Baxter Healthcare Corp1995-12-29
CONVEEN URINE BAG - STERILE (K955609)Coloplast Corp.1995-12-29
BTE CPM-10 (K955105)Baltimore Therapeutic Equipment Co.1995-12-29
SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE (K954438)Rms Div.1995-12-29
DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A (K955142)Salutron, Inc.1995-12-29
MITEK GII ANCHOR (K953877)Mitek Surgical Products, Inc.1995-12-29
AUGUSTINE INTUBATION GUIDE (K954446)Augustine Medical, Inc.1995-12-29
AXSYM DIGITOXIN (K954420)Abbott Laboratories1995-12-29
SURGEONS GLOVE POWDER FREE (K953358)American Pro Latex, Inc.1995-12-28
RANIR HI-TECHNOLOGY DENTAL FLOSS (K955530)Ranir/Dcp Corp.1995-12-28
DEGUPRINT (K955465)Degussa Corp.1995-12-28
ENDO-LEADER (K954641)Microsurge, Inc.1995-12-28
ATLANTIS (K953936)Trophy Radiologie1995-12-28
POP-N-LOK SYRINGE (K946219)Retractable Technologies, Inc.1995-12-28
ADULT VENTILATOR (K943106)Infrasonics Corp.1995-12-28
CORDIS BRITE TIP SHEATH INTRODUCER (K954595)Cordis Corp.1995-12-28
FOAM INSTRUMENT GUARD (K952787)Oxboro Medical Intl., Inc.1995-12-28
FLEXIBLE INTRAMEDULLARY REAMER (K954915)Zimmer, Inc.1995-12-28
MIDAS GOLD ELECTROFORMING SYSTEM (K955509)Austenal, Inc.1995-12-28
AQUACENTER 2000 SYSTEM (K954964)Aquarius Medical Corp.1995-12-28
D-SENSE (K955279)Centrix, Inc.1995-12-28
DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR (K952494)Nihon Seimitsu Sokki Co., Ltd.1995-12-28
FUTREX-5000 (K922600)Futrex, Inc.1995-12-28
J SINGLE USE HEAD AND JD REUSABLE HANDLE (K950555)Micro-Mega Societe Anonyme1995-12-28
ULTRAFIT LINERS (K954314)Stahmer Weston Scientific1995-12-28
SCAN WHITE 12 ML (K955406)Vident1995-12-28
BLOOD GAS MIXTURE (K954546)Liquid Technology Corp.1995-12-28
WESTMED CONDESATE COLLECTION TRAP (K954271)Westmed Intl.1995-12-28
BETA FEMORAL HIP STEM (K945774)Wrightmedicaltechnologyinc1995-12-28
AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER (K954637)American Dental Products, Inc.1995-12-28
FUTREX-5000A (K922601)Futrex, Inc.1995-12-28
TOWNLEY ALL POLY ACETABULAR CUP (K952731)Biologically Oriented Prostheses1995-12-28
A&D UN-231 ULTRASONIC HANDY NEBULIZER (K941627)A & D Corporate1995-12-28
NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE (K942977)Novoste Corp.1995-12-28
POWDER FREE PLUS PATIENT EXAMINATION GLOVE (K954855)Tillotson Healthcare Corp.1995-12-28
MEPORE PLUS (9X15CM) (K954275)Scott Health Care1995-12-27
ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES (K951910)Xintec Corporation1995-12-27
RM001 REUSABLE (K953538)American Optisurgical, Inc.1995-12-26
DF-1 TERMINAL CAP (K954551)Pacesetter, Inc.1995-12-26
HYTEC AUTOIMMUNE KIT (SS-A) (K954392)Hycor Biomedical, Inc.1995-12-26
HYTEC AUTOIMMUNE KITS (SS-B) (K954891)Hycor Biomedical, Inc.1995-12-26
HYTEC AUTOMMUNE KIT (ENA) (K954890)Hycor Biomedical, Inc.1995-12-26
DM001 DISPOSABLE PACK (K953539)American Optisurgical, Inc.1995-12-26
BIOFILL BIOCELLULOSE DRESSING STERILE (K950621)The Purdue Frederick Co.1995-12-26
EUROTROL GAS - ISE CONTROL (K955340)Direct Solutions1995-12-26
CK-MB (NAC-ACT) (K951223)Randox Laboratories, Ltd.1995-12-26
THE REEL THING (MODIFICATION) (K955439)Biomedical Devices, Inc.1995-12-26
ESP CULTURE SYSTEM - MYCO (K953129)Difco Laboratories, Inc.1995-12-26
COMBIDERM ACD (K954918)Convatec, A Bristol-Myers Squibb Co.1995-12-26
HYTEC AUTOMIMMUNE KIT (RF) (K954892)Hycor Biomedical, Inc.1995-12-26
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH (K954608)Boehringer Mannheim Corp.1995-12-26
TRANSPORT CART (K952576)Belmont Instrument Corp.1995-12-26
Multi Side Hole lnfusion System (K953384)AngioDynamics, Inc.1995-12-22
FLEXIFLO 6.1 ENTERAL NUTRITION PUMP (K951429)Ross Products1995-12-22
HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS (K954143)Hitachi Medical Corp. of America1995-12-22
TREBAY SCOPE IRRIGATED CLEARING SLEEVE (K955560)Trebay Medical Corp.1995-12-22
ENDURA REUSABLE TENS AND NMES ELECTRODES (K946230)Selectivemed Components, Inc.1995-12-22
GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT (K954562)Gynetech, Inc.1995-12-22
PLAYSKOOL (K955069)Hasbro, Inc.1995-12-22
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE (K954306)Gamp & Assoc.1995-12-22
MOBILE X-RAY SYSTEM (K955036)Shimadzu Corp.1995-12-22
MIRACLE EAR AND AUDIOTONE (K954941)Miracle-Ear, Inc.1995-12-22
MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS (K955615)Misten Medical Corp.1995-12-22
ROTABLATOR ROTATIONAL ANGIOPLASTY (K953997)Heart Technology Mfg., Inc.1995-12-22
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI (K955574)Resound Corp.1995-12-22
VOLUMETRIC INFUSION PUMP (K953098)Baxter Healthcare Corp1995-12-22
SSA-340A (K941352)Toshiba America Medical Systems, In.C1995-12-22
COBRASCAN CX-312 (K953942)Radiographic Digital Imaging, Inc.1995-12-22
RADIOSURGERY VERIFICATION PHANTOM (K954634)The Phantom Laboratory, Inc.1995-12-22
LUNG DIFFUSION MIXTURE (K954542)Liquid Technology Corp.1995-12-22
SURELOC CIRCUIT CONNECTOR (K954383)Polamedco, Inc.1995-12-22
WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP (K954649)Wilson Greatbatch Technologies, Inc.1995-12-22
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT (K945945)Philips Medical Systems North America, Inc.1995-12-22
SENSOR PAD (K955249)Inventive Products, Inc.1995-12-22
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (K952343)National Medical Care, Medical Products Div., Inc.1995-12-22
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE (K955516)Boston Medical Products, Inc.1995-12-22
GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (K954308)Gamp & Assoc.1995-12-22
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K955613)Misten Medical Corp.1995-12-22
NERVE LOCATOR/MONITOR SYSTEM MODIFICATION (K954601)Rln Systems, Inc.1995-12-22
INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS (K952889)Materials Conversion Corp.1995-12-22
GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE (K954307)Gamp & Assoc.1995-12-22
WANG TRANSENDOSCOPIC ASPIRATION NEEDLE (K954519)Mill-Rose Laboratory1995-12-22
SOF - ABRASION BUR (K955294)Trebay Medical Corp.1995-12-22
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS (K943896)Datascope Corp.1995-12-22
SPECTRADIGITAL SERIES V250DSP (K954129)Hitachi Medical Corp. of America1995-12-22
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH (K942265)Vision-Sciences, Inc.1995-12-22
TRANSIT INFUSION CATHETER WITH SIDEHOLES (K954949)Cordis Neurovascular, Inc.1995-12-22
EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY (K955593)Shippert Medical Technologies Corp.1995-12-22
ALDERSON BREST DOSIMETRY SYSTEM (K946074)Radiology Support Devices, Inc.1995-12-21
CORDIS WESTER STAR CATHETER (K954390)Cordis Webster, Inc.1995-12-21
TYMPANOSTOMY TUBE (K955447)Trebay Medical Corp.1995-12-21
CORDGUARD II (K954619)Utah Medical Products, Inc.1995-12-21
POLYMEDIC SPINAL NEEDLE AND INTRODUCER (K940061)Techniques Medicales DE Navaree1995-12-21
ECHONET (K954860)Heartlab, Inc.1995-12-21
Next →

Track 1995 automatically

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