Atlas FDA

2008

3,053 FDA 510(k) clearances · Clearance year

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
FACTS HAND AND PINCH GRIP COMBO (K073154)Global Services Group, LLC2008-02-14
PERIOSCAN, MODEL: D 3496 (K072107)Sirona Dental Systems GmbH2008-02-14
V-RASER DIODE LASER SYSTEM (K073332)Hoya Conbio, Inc.2008-02-14
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS (K073194)Cardiovascular Imaging Solutions , Ltd.2008-02-14
GC AADVA ABUTMENT (K072100)GC America, Inc.2008-02-14
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES (K073419)Rj Medical, Inc.2008-02-14
CYCLETRAC CT-5000 (K073542)Pt Products, LLC2008-02-14
VARIAX ELBOW SYSTEM (K073527)Howmedica Osteonics Corp.2008-02-14
MODIFICATION TO: APEX KNEE SYSTEM (K073602)Omnlife Science2008-02-14
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO (K080234)Teratech Corp.2008-02-14
PRO-V (K073263)Bisco, Inc.2008-02-14
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX (K080074)Ace Surgical Supply Co., Inc.2008-02-14
MECTACER BIOLOX FORTE-FEMORAL HEADS (K073337)Medacta International S.A.2008-02-13
ORIA NATURA SPACER (K073669)Choicespine, LP2008-02-13
CLAVE STOPCOCK (K080077)Icu Medical, Inc.2008-02-13
FAST1 INTRAOSSEOUS INFUSION SYSTEM (K072487)Pyng Medical Corp.2008-02-13
RELIANCE BUTTRESS WASHER SYSTEM (K073349)Reliance Medical Systems, LLC2008-02-13
ARTHREX COMPRESSION STAPLE (K080111)Arthrex, Inc.2008-02-13
DIMERTEST (K080069)American Diagnostica, Inc.2008-02-13
THOR ANTERIOR PLATING SYSTEM (K073437)Stryker Spine2008-02-13
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) (K072955)Smiths Medical MD, Inc.2008-02-13
QUANTA LITE H-TTG SCREEN (K073145)Inova Diagnostics, Inc.2008-02-12
SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE (K071432)Fox Hollow Technologies2008-02-12
SINGLE STEP MEDIUM (K072609)Irvine Scientific Sales Co., Inc.2008-02-12
REPROCESSED SCISSOR TIPS (K073613)Sterilmed, Inc.2008-02-12
ANKYLOS TEMPORARY ABUTMENT BALANCE (K073073)Dentsply International, Inc.2008-02-12
AFINION ACR AND ACR CONTROL (K072409)Axis-Shield Poc AS2008-02-12
INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 (K071307)Inviro Medical Devices, Inc.2008-02-12
WATERLASE AND WATERLASE MD (K071363)Biolase Technology, Inc.2008-02-12
MILTEX RIGID CONTAINER SYSTEMS (K072563)Miltex, Inc.2008-02-12
AG-CLASSIC (K072494)Medel S.P.A.2008-02-12
QUANTA PLEX CELIAC IGG PROFILE (K072632)Inova Diagnostics, Inc.2008-02-11
KODAK 9000, KODAK 9000 3D (K073435)Trophy2008-02-11
OLYMPUS IGA REAGENT (K073489)Olympus America, Inc.2008-02-11
ARTIS ZEE AND ZEEGO (K073290)Siemens Medical Solutions USA, Inc.2008-02-11
OLYMPUS IGG REAGENT (K073490)Olympus America, Inc.2008-02-11
OLYMPUS IGM REAGENT (K073487)Olympus America, Inc.2008-02-11
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM (K073510)Endius, Inc.2008-02-11
MENISCAL CINCH (K073149)Arthrex, Inc.2008-02-11
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 (K080062)Hitachi Medical Systems America, Inc.2008-02-11
SYNTHES ZERO-P (K072981)Synthes Spine Co.Lp2008-02-11
15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2) (K071794)Totoku Electric Co., Ltd.2008-02-11
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM (K073241)Vascular Pathways2008-02-08
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE (K073188)Smiths Medical Asd, Inc.2008-02-08
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) (K072228)Pinnacle Co., Ltd.2008-02-08
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES (K073024)Masimo Corporation2008-02-08
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 (K080249)Ultradent Products, Inc.2008-02-08
PROVENT NASAL DILATOR, MODEL BR2 (K071560)Ventus Medical, Inc.2008-02-08
DIVE AND SHALLOW AND GRAND DIVE (K072757)Summit TO Sea2008-02-08
SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING (K073162)Kensey Nash Corporation2008-02-08
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041 (K073366)Shenzhen Dongdixin Technology Co., Ltd.2008-02-08
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS (K072947)ClearStream Technologies , Ltd.2008-02-08
LED PRO SEAL (K073243)Reliance Orthodontic Products, Inc.2008-02-08
OCCLUSION BALLOON CATHETER (K070126)Sentreheart, Inc.2008-02-08
BIOHORIZONS INTERNAL IMPLANT SYSTEM (K073268)BioHorizons Implant Systems, Inc.2008-02-08
DYNESYS TOP-LOADING SPINAL SYSTEM (K073347)Zimmer Spine, Inc.2008-02-08
GRIND GUARD (K073446)Archtek, Inc.2008-02-08
HEARTSTRING III PROXIMAL SEAL SYSTEM (K080169)Guidant Corporation, Cardiac Surgery2008-02-08
COLLAWOUND HYDROGEL (K071557)Collamatrix Co., Inc.2008-02-08
REUSABLE HEADREST WITH NASAL SEAL (K072993)Aeiomed, Inc.2008-02-08
MEDLINE DISPOSABLE VAGINAL SPECULUM (K072942)Medline Industries, Inc.2008-02-08
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM (K080160)Toshiba America Medical Systems, In.C2008-02-08
BIO-MAT 2000 (K072534)Richway Intl., Inc.2008-02-08
STAR 55 (K080173)Larsen & Toubro Limited2008-02-08
RK EPIDURAL NEEDLE (K072005)Epimed International2008-02-07
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE (K080240)Promident, LLC2008-02-07
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY (K073003)Siemens Medi Cal Solutions, Inc.2008-02-07
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER (K072627)Intuitive Surgical, Inc.2008-02-07
CIMPLICITY SPINAL SYSTEM (K073320)Spine Smith Partners L.P.2008-02-07
ANCHORAGE CLOSURE DEVICE (K073096)Epitek, Inc.2008-02-07
SIDEKICK RAIL FIXATOR (K080071)Wrightmedicaltechnologyinc2008-02-07
SANATMETAL NAILS AND PINS (K070761)Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod.2008-02-07
SANARUS V2 TREATMENT SYSTEM (K073533)Sanarus Medical, Inc.2008-02-07
PROSTIM 1000/2000 (K073438)Bio Protech, Inc.2008-02-07
HUMAN HEART VALVE, CRYOVALVE SG (K033484)Cryolife, Inc.2008-02-07
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 (K073650)Fujifilm Medical Systems U.S.A, Inc.2008-02-06
MSK EXTREME MR SCANNER, MODEL AA5000 (K080048)Oni Medical Systems, Inc.2008-02-06
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 (K072412)Drager Medical AG & Co. Kgaa2008-02-06
PSL BIOZIR BLOCK (K073568)P.S.L. International, Inc.2008-02-06
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 (K072899)Aesculap Implant Systems, Inc.2008-02-06
MERITS E600 SERIES STAIR LIFT (K073110)Merits Health Products Co., Ltd.2008-02-06
WELL-PEX (K080266)Vericom Co., Ltd.2008-02-06
DENFIL ETCHANT-37 (K080265)Vericom Co., Ltd.2008-02-06
DYNASTY CERAMIC FEMORAL HEAD (K072656)Wrightmedicaltechnologyinc2008-02-06
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (K073224)Procter & Gamble2008-02-06
ATLAS IMPLANT SYSTEM (K071148)Cowellmedi Co., Ltd.2008-02-06
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (K062798)Cordis Corp.2008-02-06
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM (K073626)Bio-Logic Systems Corp.2008-02-05
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM (K072254)Interacoustics A/S2008-02-05
NRBC-CHEX FOR ADVIA (K080016)Streck2008-02-05
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET (K072437)Roche Diagnostics2008-02-05
MODIFICATION TO:HEALTH BUDDY APPLIANCE (K080091)Health Hero Network, Inc.2008-02-05
PATHFAST NTPROBNP AND D-DIMER TESTS (K072189)Mitsubishi Kagaku Iatron2008-02-05
STATMATIC 31 HANDPIECE MAINTENANCE UNIT (K073319)Scican , Ltd.2008-02-04
MS SYSTEM (DENTURE) (K072959)Osstem Implant Co., Ltd.2008-02-04
MUSMATE WALKING AID (K073521)Musmate, Ltd.2008-02-04
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT (K072857)Medacta International S.A.2008-02-04
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY (K072908)Gambro Renal Products2008-02-04
ACCIN PEDICLE SCREW SYSTEM (K073531)Accelerated Innovation, LLC2008-02-04
NEUN (K073554)Heraeus Kulzer,GmbH2008-02-04
← Previous Next →

Track 2008 automatically

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