Atlas FDA

2014

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

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RecordFirmDate
CANTATA(R) 2.9 MICROCATHETER (K131772)Cook, Inc.2014-02-20
JMS SYRINGE (K132321)JMS North America Corporation2014-02-20
INFANT PHOTOTHERAPY BILITRON SKY 5006 (K131196)Fanem Lda2014-02-20
JAZZ SYSTEM (K133617)Implanet, S.A.2014-02-20
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (K133076)Neometrics, Inc.2014-02-20
INBONE TOTAL ANKLE (K133585)Wrightmedicaltechnologyinc2014-02-20
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM (K133567)Globus Medical, Inc.2014-02-20
RELIEVA SCOUT SINUS DILATION SYSTEM (K140160)Acclarent, Inc.2014-02-20
ADVANCED PERFUSION SYSTEM 1 (K131041)Terumo Cardiovascular Systems Corp.2014-02-20
PROINSERT (K131145)Nidacon International AB2014-02-20
30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) (K140214)Jvckenwood Corporation2014-02-19
MEDICINAL LEECHES (K132958)Biopharm (Uk) , Ltd.2014-02-19
RS-3000 ADVANCE (K132323)Nidek Co., Ltd.2014-02-19
DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM (K140030)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2014-02-19
MEDOS HILITE INFANT OXYGENATOR (K140181)Medos Medizintechnik AG2014-02-19
MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE (K140170)Cardica, Inc.2014-02-19
MODIFICATION TO NAUTILUS SPINAL SYSTEM (K133564)Life Spine, LLC2014-02-19
8MM TROCAR KIT (K133845)Intuitive Surgical2014-02-19
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130800)Kaixuan Plastic Co., Ltd.2014-02-18
SARNS SOFT-FLOW AORTIC CANNULA (K132451)Terumo Cardiovascular Systems Corp.2014-02-18
TIDISHEILD (K132953)Tidi Products,Llc2014-02-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130809)Jewel Plastic Co., Ltd.2014-02-18
A SERIES AND Q SERIES PATIENT MONITORS (K131898)Guangdong Biolight Meditech Co., Ltd.2014-02-18
COMPRESSIBLE LIMB SLEEVE SYSTEM (K130385)Maxstar Industrial Co., Ltd.2014-02-18
MEDOS HILITE OXYGENATOR (K140177)Medos Medizintechnik AG2014-02-18
KASM KNEE ARTICULATING SPACER MOLDS (K133449)Ortho Development Corp.2014-02-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K130891)Friend Plastic Co., Ltd.2014-02-18
POWERPORT IMPLANTABLE PORT (K133335)C.R. Bard, Inc.2014-02-14
AIRSTRIP REMOTE PATIENT MONITORING (K133450)Airstrip Technologies, LP2014-02-14
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) (K132909)Becton, Dickinson and Company2014-02-14
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE (K140136)Nipro Medical Corporation2014-02-14
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE (K134004)Cellco Partnership D/B/A Verizon Wireless2014-02-14
MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR (K133708)Nec Display Solutions , Ltd.2014-02-14
STELLARIS VISION ENHANCEMENT SYSTEM (K133242)Bausch & Lomb2014-02-14
ANGIOJET ULTRA AVX THROMBECTOMY SET (K133629)Possis Medical, Inc.2014-02-14
REVEAL LINQ INSERTABLE CARDIAC MONITOR (K132649)Medtronic, Inc.2014-02-14
NMI DIALYSIS CATHETER (K131260)Navilyst Medical, Inc.2014-02-14
VICTUS FEMTOSECOND LASER PLATFORM (K132534)Technolas Perfect Vision GmbH2014-02-14
L.A.M. IPM WOUND GEL, IPM DERM GEL (K130781)Glycobiosciences, Inc.2014-02-14
XCATH (K133296)Alseal2014-02-14
3MP GRAYSCAKE LCD DISPLAY (K140103)Shenzhen Beacon Display Technology Co., Ltd.2014-02-14
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (K132192)Bracco Diagnostic, Inc.2014-02-14
DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL (K132212)Hager& Meisinger GmbH2014-02-14
SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS (K132426)Sylphar N.V.2014-02-14
3MP COLOR LCD DISPLAY (K140108)Shenzhen Beacon Display Technology Co., Ltd.2014-02-14
TREZ_HD (K131266)Excel-Tech Ltd. (Xltek)2014-02-14
MANUAL WHEELCHAIR (K132257)Zhejiang Jiafeng Electrical & Mechanial Co., Ltd.2014-02-13
INTRODUCER SETS, MODEL ADELANTE RADIAL (K130633)Oscor, Inc.2014-02-13
ACTIVAPATCH ET IONTOPHORESIS PATCH (K132832)Activatek, Inc.2014-02-13
BARRICADE EMBOLIZATION COIL SYSTEM (K140104)Blockade Medical2014-02-13
PALS PLATINUM NEUROSTIMULATION ELECTRODES (K132422)Axelgaard Mfg. Co., Ltd.2014-02-13
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES (K130930)Ningbo Lishunda Electronics Co., Ltd.2014-02-12
KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD (K131454)Total Joint Orthopedics, Inc.2014-02-12
PHYSIOFLOW Q-LINK (K140102)Vasocom, Inc.2014-02-12
PTFE SURGICAL SUTURE (K132464)Omnia Spa2014-02-12
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM (K132582)Exactech, Inc.2014-02-12
POWERHEART G5 AED (K122758)Cardiac Science Corporation2014-02-12
MEPITEL AG (K130040)Molnlycke Health Care2014-02-12
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K131033)Decent Plastic Co., Ltd.2014-02-12
15 FR. TANDEMHEART ARTERIAL CANNULA (K133293)Cardiacassist, Inc.2014-02-12
LIGER MEDICAL ESU-110 (K133273)Liger Medical, LLC2014-02-12
GEODESICEEG SYSTEM 400 SERIES (GES 400) (K131882)Electrical Geodesics, Inc.2014-02-12
METRIXCARE (K132424)The Metrix Company2014-02-12
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; (K131154)Zevex, Inc.2014-02-12
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH (K132720)Merit Medical Systems, Inc.2014-02-12
C-BOX PEEK CERVICAL IBF (K132991)Innovasis, Inc.2014-02-12
RESTORELLE Y CONTOUR MESH (K140116)Coloplast A/S2014-02-12
SHASER V-MINI 2 HAIR REMOVAL SYSTEM (K133201)Shaser, Inc.2014-02-12
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION (K133476)Carl Zeiss Meditec, AG2014-02-12
LOGIQ E (K133533)GE Healthcare2014-02-12
POWDER FREE LATEX EXAMINATION GLOVES (K123537)Qube Medical Product Sdn Bhd2014-02-12
MDIXON-QUANT (K133526)Philips Medical Systems Nederland B.V.2014-02-12
CONVENTUS DRS (K131552)Conventus Orthopaedics2014-02-12
VENA PRO (K133274)Innovamed Health, LLC2014-02-12
HYPERSOUND AUDIO SYSTEM (HSS) (K133352)Hypersound Health, Inc.2014-02-12
ADHESE UNIVERSAL (K133318)Ivoclar Vivadent, AG2014-02-11
DANA REUSABLE TEST PACK (K133267)Dana Products, Inc.2014-02-11
JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD (K132472)Justright Surgical, LLC2014-02-11
CONTROL SEAL (K130485)Voco GmbH2014-02-11
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK (K132925)Amendia, Inc.2014-02-11
EQUINOXE EXTRA SHORT HUMERAL HEAD (K140063)Exactech, Inc.2014-02-11
ENDORINGS (K133359)Endo-Aid, Inc.2014-02-11
V8 TRANSLUMINAL BAV CATHETER (K133607)Intervalve, Inc.2014-02-11
GUAVA II (K122632)Cardiocomm Solutions, Inc.2014-02-11
EZ-IO INTRAOSSEOUS INFUSION SYSTEM (K132583)Vidacare Corporation2014-02-11
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY (K140117)Orthocon, Inc.2014-02-11
OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 (K133583)Interventional Spine, Inc.2014-02-10
IMRI 1.5T AND IMRI 3T S (K133692)Imris, Inc.2014-02-10
AQUILION ONE VISION (K133497)Toshibamedical Systems Corporation2014-02-10
CITRISOL ACID CONCENTRATE (K130511)Diasol, Inc.2014-02-10
ARTASSIST AND VENASSIST (K131146)Aci Medical, LLC2014-02-10
NEXXZR(TM)T AND NEXXZR(TM)S (K130991)Sagemax Bioceramics, Inc.2014-02-10
C-PLUS (K133623)Pioneer Surgical Technology, Inc.2014-02-10
TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS (K133477)Synchro Medical2014-02-10
RING-LOK MODULAR BIPOLAR SYSTEM (K132539)Implants International, Ltd.2014-02-07
PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) (K133263)Proteus Digital Health, Inc.2014-02-07
DUOCENTRIC REVERSED SHOULDER PROSTHESIS (K133462)Aston Medical2014-02-07
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES (K130616)Biopsybell S.R.L.2014-02-07
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130807)Hope Plastic Co., Ltd.2014-02-07
ALERTWATCH: OR (K130401)Alertwatch, LLC2014-02-07
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Every clearance here is in the API, with alerts when new ones post.