Atlas FDA

2014

3,202 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM (K133389)Eps Bio Technology Corp.2014-04-15
CERVICAL STAND ALONE SYSTEM (K132999)Orthofix, Inc.2014-04-14
CABOCHON SYSTEM (K134010)Cabochon Aesthetics, Inc.2014-04-14
AVANCE® FOAM ABDOMINAL DRESSING KIT (K130852)Molnlycke Health Care2014-04-14
DISCOSCOPES, CERVICAL ENDOSCOPES (K130778)Rz Medizintechnik GmbH2014-04-14
PICASSO II MIS SPINAL SYSTEM (K140219)Accel Spine2014-04-14
ELISIO-H HEMODIALYZER (K140191)Nipro Medical Corporation2014-04-14
MYHEALTHPOINT TELEHEALTH MANAGER (K132930)Entra Health Systems2014-04-14
ERCHONIA ALLAY (K132940)Erchonia Medical, Inc.2014-04-14
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (K133957)Galemed Corp.2014-04-14
NAMIC RCS SYRINGE (K140194)Navilyst Medical, Inc.2014-04-14
GIBRALT ROD-TO-ROD CROSS CONNECTORS (K140645)Exactech Sarasota2014-04-11
SPINEWORKS ANTERIOR LUMBAR DEVICE (K133340)Spineworks, LLC2014-04-11
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM (K132312)Renovis Surgical Technologies, LLC2014-04-11
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE (K132138)Rhythmlink International, LLC2014-04-11
AZE PHOENIX SOFTWARE (K133521)Aze, Ltd.2014-04-11
REVEEL ENDOSCOPIC RETRACTOR (K133345)Retraction Limited2014-04-11
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) (K131883)Inovise Medical, Inc.2014-04-11
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET (K133923)Reflectance Medical, Inc.2014-04-11
REVOLUTION CT (K133705)Ge Medical Systems, LLC2014-04-11
AIR-FLOW HANDY 3.0 (K132478)E.M.S Electro Medical Systems S.A2014-04-11
INION FREEDOMPIN (K133932)Inion OY2014-04-11
DAYTONA ICG (P200TICG) (K134039)Optos Plc.2014-04-11
DECLIPSESPECT LAPAROSCOPY (K133781)Surgiceye GmbH2014-04-11
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G (K140646)Rayence Co., Ltd.2014-04-11
M-PM-DISC (K134015)Merz Dental GmbH2014-04-11
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE (K131906)Satelec - Acteon Group2014-04-11
POWDERED VINYL EXAMINATION GLOVES (K122176)Shu Tong Xinghua Co., Ltd.2014-04-11
PROPOSED OPTIMUS (K132596)Custom Spine, Inc.2014-04-11
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS (K134047)Integra LifeSciences Corporation2014-04-11
ALL-BOND UNIVERSAL SC (NOT FINALIZED) (K131734)Bisco, Inc.2014-04-11
POWDER FREE VINYL EXAMINATION GLOVES (K122377)Shu Tong Xinghua Co., Ltd.2014-04-11
DUALGUARD (K140473)Flexicare Medical, Ltd.2014-04-10
STREAMLINE TL SPINAL FIXATION SYSTEM (K140696)Pioneer Surgical Technology, Inc.2014-04-10
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER (K133578)Stryker Sustainability Solutions2014-04-10
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) (K131028)Pentax Medical Company2014-04-10
ONTEX AND OTHERS PROPRIETARY NAMES (K132208)Ontex Bvba2014-04-10
RETROMTA-ORTHOMTA II (K132825)Biomta2014-04-10
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES (K132290)Materialise NV2014-04-10
BIO-PROBE TRANSDUCER (ADULT) (K133903)Medtronic, Inc.2014-04-10
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM (K133045)Infopia Co, Ltd.2014-04-10
IEEG (K131944)Jordan Neuroscience, Inc.2014-04-10
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (K140042)LeMaitre Vascular, Inc.2014-04-10
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM (K140339)Covidien2014-04-10
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) (K131902)Pentax Medical Company2014-04-10
VECTRA NEO CLINICAL THERAPY SYSTEM (K132284)Djo, LLC2014-04-10
MULTIX SELECT DR (K132934)Siemens Medi Cal Solutions, Inc.2014-04-10
CONTOUR I V3.1 SYSTEM (K133238)Syneron Medical, Ltd.2014-04-10
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET (K140648)Tosoh Bioscience, Inc.2014-04-10
EMERGENCY PORTABLE VENTILATOR (K131098)Allied Healthcare Products, Inc.2014-04-09
SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM (K131563)Opus Ksd, Inc.2014-04-09
VIORA V-TOTAL (K133837)Viora , Ltd.2014-04-09
LEXICONTURE MECHANICAL DILATOR SHEATH SET (K140047)Spectranetics Corp.2014-04-09
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS (K140609)Covidien2014-04-09
ZELTIQ COOLSCULPTING SYSTEM (K133212)Zeltiq Aesthetics, Inc.2014-04-09
TRC-PASTE (K133716)Km Corporation2014-04-09
CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM (K132009)Schoelly Fiberoptic GmbH2014-04-09
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY (K123555)Covidien2014-04-09
HTFX-222 (K133182)GC America, Inc.2014-04-09
PENTAX VIDEO COLONOSCOPES (EC FAMILY) (K131855)Pentax Medical Company2014-04-09
MEGA ISQ (K132401)Osstell AB2014-04-09
STRYKER TEMPORARY CONDYLAR PROSTHESIS (K133285)Stryker2014-04-09
MD-FLEX HEAVY BODY (K134008)Meta Biomed, Inc.2014-04-09
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K133949)Top Calibre Sdn Bhd2014-04-08
THE GYNOCULAR (K132423)Gynius AB2014-04-08
ORTHROS POSTERIOR STABILIZATION SYSTEM (K133366)Camber Spine2014-04-08
ULTRAFUSE (K130531)Baxter Healthcare Corp2014-04-08
SURGICAL LIGHT HANDLE COVER (K133554)Microtek Medical, Inc. an Ecolab Company2014-04-08
WUNDER PREGNANCY TEST (K130456)James Nguyen2014-04-08
MANDREL GUIDEWIRE (K140482)Lake Region Medical2014-04-08
FLIGHT 60 VENTILATOR (K130171)Flight Medical Innovations , Ltd.2014-04-08
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) (K140089)Guangzhou Wondfo Biotech Co., Ltd.2014-04-08
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 (K140069)Merete Medical GmbH2014-04-07
BAXANO SURGICAL MIS SPINAL SYSTEM (K133743)Baxano Surgical, Inc.2014-04-07
SPEED TRIAD (K133844)Biomedical Ent., Inc.2014-04-07
THREADED PEEK K-WIRE (K133235)Mtp Solutions, LLC2014-04-07
FRAGMENT PLATE SYSTEM (K140372)Skeletal Dynamics, LLC2014-04-07
SYNGO DUAL ENERGY SOFTWARE PACKAGE (K132902)Siemens Medical Solutions USA, Inc.2014-04-07
HYDROPHILIC COATED GUIDEWIRE (K133155)Lake Region Medical2014-04-07
ABACUS TM SPACER SYSTEM (K140007)Spine Wave, Inc.2014-04-07
NORDICBRAINEX (K133910)Nordicneurolab2014-04-04
TSP HIP FRACTURE PLATING SYSTEM (K140018)Biomet, Inc.2014-04-04
ARTUS C. DIFFICILE QS-RGQ MDX KIT (K133936)QIAGEN GmbH2014-04-04
CLOUDEKG (K130878)Makromed, Inc.2014-04-04
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE (K133377)Nobel Biocare AB2014-04-04
AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL (K130959)Bioplax Limited2014-04-04
MEDINAUT KYPHOPLASTY SYSTEM (K133669)Imedicom2014-04-04
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW (K132911)In2bones Sas2014-04-04
US ENDOSCOPY DISTAL ATTACHMENT CAP (K140315)United States Endoscopy Group, Inc.2014-04-04
A1C GEAR SYSTEM (K130014)Sakae Corporation2014-04-04
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT (K132381)Clearmri Solutions, Inc.2014-04-04
BARD RITECATH INTERMITTENT CATHETER (K133470)C.R. Bard, Inc.2014-04-04
8MP COLOR LCD MONITOR, RADIFORCE RX850 (K140702)Eizo Corporation2014-04-04
ARIA RADIATION THERAPY MANAGEMENT (K133572)Varian Medical Systems, Inc.2014-04-04
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR (K133777)Tornier, Inc.2014-04-04
TRIBALL INCENTIVE SPIROMETER (K133873)Besmed Health Business Corp2014-04-04
CRYOTOP(R) SC (K140072)Kitazato Biopharma Co., Ltd.2014-04-03
FLEXIBLE COOAGEN NERVE CUFF (K131541)Collagen Matrix, Inc.2014-04-03
COROENT SMALL INTERBODY SYSTEM (K140003)Nuvasive, Inc.2014-04-03
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET (K130757)Spencer Fillmore2014-04-03
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Every clearance here is in the API, with alerts when new ones post.