Atlas FDA

2014

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

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RecordFirmDate
SYNTHETIC ABSORBABLE SUTURE (K130737)Foosin Medical Supplies Inc., Ltd.2014-01-14
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S (K132984)Ivoclar Vivadent, Inc.2014-01-14
SYNTHETIC ABSORBABLE SUTURE (K130735)Foosin Medical Supplies Inc., Ltd.2014-01-14
M2 WRIST 2 MRI SYSTEM (K130692)Aspect Imaging, Ltd.2014-01-14
GEM PREMIER 4000 (K133407)Instrumentation Laboratory CO2014-01-13
K SERIES CPAP SYSTEMS (K130828)Curative Medical, Inc.2014-01-13
PROXIFAST ABSORBABLE STAPLE (K132669)Surgimatix, Inc.2014-01-13
SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM (K133066)Spineselect, LLC2014-01-13
S9 CRONULLA FOR HER (K132606)Resmed, Ltd.2014-01-13
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE (K130674)Xeridiem Medical Devices2014-01-13
SANTIS PEDICLE SCREW SYSTEM (K133063)Lanterna Medical Technologies2014-01-13
CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), (K131410)Southmedic, Inc.2014-01-13
MODIFIED TREVO PROVUE RETRIEVER (K132641)Concentric Medical, Inc.2014-01-13
MIXING SYRINGE SYSTEM (K133021)Zimmer Knee Creations, Inc.2014-01-13
CT PULMONARY ANALYSIS (K130552)Qi Imaging, LLC2014-01-13
ULTRABLOX (K133684)Bloxr Corporation2014-01-13
BIOACTIVE BONE GRAFT PUTTY (K132071)Biostructures, LLC2014-01-10
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY (K130235)Hans Biomed Corp.2014-01-10
AXIUM DETACHABLE COIL SYSTEM (K133310)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-01-10
FUJIFILM 600 SERIES ENDOSCOPES (K132210)Fujifilm Medical Systems U.S.A, Inc.2014-01-10
FLEXMAP 3D (K133302)Luminex Corp.2014-01-10
NERVE CUFF (K132660)Cook Biotech Incorporated2014-01-10
ANNEXTM ADJACENT LEVEL SYSTEM (K132403)Spine Wave, Inc.2014-01-10
CL10009 IR LASER (K130168)Curae'Lase, Inc.2014-01-10
PROBEAM PROTON THERAPY SYSTEM (K133191)Varian Medical Systems2014-01-10
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (K132076)Dsrv, Inc.2014-01-10
PANPAC WORD/BARTHOLIN CATHETER (K130087)Panpac Medical Corporation2014-01-10
ET PROSTHETIC SYSTEM (K130662)Osstem Implant Co., Ltd.2014-01-10
REAGENT, RUSSEL VIPER VENOM - LA SCREEN (K132130)Dsrv, Inc.2014-01-10
DIGIFIX EXTERNAL FIXATION SYSTEM (K132731)Virak Orthopedic Research, LLC2014-01-10
ULTRASOUND SCANNER FLEX FOCUS 1202 (K132335)B-K Medical Aps2014-01-10
ULTRASOUND SCANNER PRO FOCUS 2202 (K132346)B-K Medical Aps2014-01-10
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (K133604)The Anspach Effort, Inc.2014-01-10
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT (K131554)Randox Laboratories, Ltd.2014-01-09
TAMPAX M PLASTIC TAMPONS, UNSCENTED (K133244)The Procter & Gamble Company2014-01-09
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K133256)Conformis, Inc.2014-01-09
ISO-GARD MASK (K132729)Teleflexmedical, Inc.2014-01-09
SONOPULSE/ SONOPULSE III (K130888)Ibramed- Industria Brazileria DE Equipamentos Medi2014-01-09
ALAMO C (K133321)Alliance Partners, LLC2014-01-09
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM (K121235)Stryker2014-01-09
CRYOLOCK (K122982)Biotech, Inc.2014-01-09
RAMPART-L (K133371)Spineology, Inc.2014-01-09
MEDOS HILITE 7000 & 7000 LT OXYGENATOR (K133261)Medos Medizintechnik AG2014-01-09
CASCADE HEMODIALYSIS/APHERESIS CATHETER (K130851)Health Line International Corporation2014-01-09
HAMMERLOCK 2 (K133520)Biomedical Enterprises, Inc.2014-01-09
FASTEP S10 HCG SERUM/URINE COMBO TEST (K132834)Polymed Therapeutics, Inc.2014-01-09
MIDLINE (TM) (K133286)Centinel Spine, Inc.2014-01-09
ACTIM PROM (K123986)Alere Scarborough, Inc.2014-01-09
BAUSCH & LOMB INJECTOR SYSTEM (K131958)Bausch & Lomb2014-01-09
ENDO GIA(TM) EXTRA LONG ADAPTER (K133762)Covidien, LLC2014-01-08
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE (K130476)Dental Morelli2014-01-08
OCCLUDER OCCLUSION BALLOON CATHETER (K133750)Boston Scientific Corporation2014-01-08
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE (K132880)Medical Components, Inc.2014-01-08
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM (K133452)Emerge Medical2014-01-08
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM (K133747)Endochoice, Inc.2014-01-08
ULTRASONIC MESH NEBULIZER (K132247)Foshan Gaunying Electronics Co., Ltd.2014-01-08
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (K132843)Nanosphere, Inc.2014-01-08
V-PATCH SYSTEM (K131000)Intelesens Limited2014-01-08
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (K130843)Oscor, Inc.2014-01-08
ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER (K130681)Biolitec Sia2014-01-08
3I T3(R) EXTERNAL HEX DENTAL IMPLANTS (K133049)Biomet 3i2014-01-08
ULTRASOUND SCANNER FLEX FOCUS 1202 (K132677)B-K Medical Aps2014-01-07
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K131832)Shandong Binxiang Medical Products Co., Ltd.2014-01-07
AXIA RADIAL HEAD SYSTEM (K132735)Imds (Innovative MEdical Device Systems) - Leis ME2014-01-07
D-RAD SMART PACK (K132296)Smith & Nephew, Inc.2014-01-07
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD (K133167)Intuitive Surgical, Inc.2014-01-07
IDSS SLC (K133413)Black Diamond Video2014-01-07
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER (K130122)Beckman Coulter, Inc.2014-01-07
MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS (K124033)Surgical Instruments Service and Savings, Inc.2014-01-07
MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE (K132581)Cardica, Inc.2014-01-07
ENDOSCOPIC SUTURE CUTTER (K133736)United States Endoscopy Group, Inc.2014-01-07
INTONEMV (K133826)Incontrol Medical, LLC2014-01-06
ACUMED HAND PLATING SYSTEM (K132769)Acumed, LLC2014-01-06
ULTRASOUND SCANNER PRO FOCUS 2202 (K132685)B-K Medical Aps2014-01-06
OPTIFLUX ULTRA DIALYZER (K123262)Fresenius Medical Care North America2014-01-06
SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER (K132439)Sakura Seiki Co., Ltd.2014-01-06
DISTALOCK TIBIAL IM NAIL SYSTEM (K132830)Dgimed Ortho, Inc.2014-01-06
LATERAL SYNFIX (K131276)Synthes (USA) Products, LLC2014-01-06
ACON ON CALL DIABETES MANAGEMENT SOFTWARE (K131469)ACON Laboratories, Inc.2014-01-06
LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI (K131461)Led Intellectual Properties, LLC2014-01-06
21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) (K133686)Jvckenwood Corporation2014-01-06
FMWAND FERROMAGNETIC SURGICAL SYSTEM (K130606)Domain Surgical, Inc.2014-01-03
WAVE 2G, SOUL (K130937)Hansaton Akustik GmbH2014-01-03
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES (K132733)Orthohelix Surgical Designs, Inc.2014-01-03
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM (K131880)Spinefrontier, Inc.2014-01-03
TRU FLU (K133714)Meridian Bioscience, Inc.2014-01-03
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL (K132399)Elitechgroup2014-01-03
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K133312)Boston Scientific Corporation2014-01-03
PRISMAFLEX SYSTEM 7.10 (K131516)Gambro Renal Products, Inc.2014-01-03
SYNGO.VIA WEB VIEWER (K130998)Siemens AG Medical Solutions2014-01-03
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM (K133645)Medtronic Sofamor Danek USA, Inc.2014-01-03
FUSION SINGLE LINK (K132923)Angelus Industria DE Productos Odontologicos SA2014-01-03
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES (K133224)Conmed Corporation2014-01-03
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146)Bausch & Lomb2014-01-03
SIREN EPCR SUITE (K131272)Medusa Medical Technologies, Inc.2014-01-03
SOMATOM DEFINITION AS OPEN (K130901)Siemens Medical Systems, Inc.2014-01-02
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING (K130670)Hydrofera, LLC2014-01-02
SPEC MODEL M15 (K132969)Source Production & Equipment Co., Inc.2014-01-02
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) (K133512)Siemens Healthcare Diagnostics2014-01-02
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (K131364)KARL STORZ Endoscopy-America, Inc.2014-01-02
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