Atlas FDA

2014

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

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RecordFirmDate
THERMEDX FLUID MANAGMENT SYSTEM (K133799)Thermedx, LLC2014-06-20
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK (K140155)Cardinal Health200, LLC2014-06-20
ADMIRE (K133646)Siemens Medical Systems, Inc.2014-06-20
ENCOMPASS 10/12 HIP STEM (K132697)Ortho Development Corp.2014-06-20
DIAPHRAGMATIC HERNIA GRAFT (K133011)Cook Biotech, Inc.2014-06-20
ULTHERA SYSTEM (K134032)Ulthera, Inc.2014-06-20
INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) (K132489)Inogen, Inc.2014-06-20
RADSPA (K141329)Telerad Tech Private Limited2014-06-20
AXSOS 3 TI LOCKING PLATE SYSTEM (K141121)Stryker Trauma AG2014-06-20
QUENTRY DOSE REVIEW (K141199)Brainlab AG2014-06-20
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX (K140278)Somnomed, Inc.2014-06-20
BRACCO INJEENERING TRANSFER SET (K133147)Bracco Injeneering S.A.2014-06-20
VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM (K141204)Stryker Trauma AG2014-06-20
PROCEM (K140644)Ototronix, LLC2014-06-19
JR IMPLANT SYSTEM (K130694)LK Consulting Group USA, Inc.2014-06-19
DISPOSABLE PRESSURE MANOMETER (K140370)Besmed Health Business Corp2014-06-19
TRUFREEZE SYSTEM (K133258)CSA Medical, Inc.2014-06-19
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER (K132891)The Hymed Group Corp.2014-06-19
OSSEOFLEX SB (K140937)Osseon, LLC2014-06-19
SILDENT (K132869)Hrs Co., Ltd.2014-06-19
COSMOLOCK PEDICLE SCREW SYSTEM (K140678)Kalitec Direct, LLC2014-06-19
MIROMATRIX WOUND MATRIX (K140510)Miromatrix Medical, Inc.2014-06-19
ABBVIE PEG (K133087)AbbVie , Inc.2014-06-19
ABBVIE NJ (K133129)AbbVie , Inc.2014-06-19
REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM (K141313)Reverse Medical Corporation2014-06-18
ABB VIE J (K133096)AbbVie , Inc.2014-06-18
QARDIOARM (K140067)Qardio, Inc.2014-06-18
TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM (K141029)Tornier, Inc.2014-06-18
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER (K141363)Merit Medical Systems, Inc.2014-06-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130733)Benteng Plastic Co., Ltd.2014-06-18
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES (K140583)Grandway Technology (Shenzhen) Limited2014-06-18
QUALIS (K133295)Menicon Co., Ltd. New Business Division2014-06-18
KONIX STERILE GEL (K130581)Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2014-06-18
EASYPOINT NEEDLE (K133635)Retractable Technologies, Inc.2014-06-17
KEELER KAPTURE SOFTWARE (K140450)Keeler Limited2014-06-17
S9 WANDA VPAP ST (K140159)Resmed, Ltd.2014-06-17
BI-FLEX URETERAL ACCESS SHEATH (K140441)Promepla Sam2014-06-17
ULTRA RENEW PLUS (K132833)Accord Media2014-06-17
WIJAY EZ-VOID EXTERNAL CATHETER VALVE (K140562)Leomed, LLC2014-06-16
ARTHROCARE NASASTENT CMC NASAL DRESSING (K140992)ArthroCare Corporation2014-06-16
NXSTAGE EXPRESS FLUID WARMER (K140623)Nxstage Medical, Inc.2014-06-16
ARIETTA 60/ARIETTAS60/ARIETTAV60 (K140443)Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014-06-16
BONASTENT BILIARY (K140760)Endochoice, Inc.2014-06-16
CHAIRSIDE ATTACHMENT PROCESSING MATERIAL (K140570)Zest Anchors, LLC2014-06-16
ENDOSHIELD BURN PROTECTION SYSTEM (K140006)Encision, Inc.2014-06-16
RECOVERY PUMP 737R (K140519)Mego Afek AC , Ltd.2014-06-16
U2 FEMORAL COMPONENT, CR, CEMENTED (K140073)United Orthopedic Corp.2014-06-16
GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM (K132289)Gemss Medical Systems Co., Ltd.2014-06-16
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (K140215)Co-Innovation Biotech Co., Ltd.2014-06-16
PLANMECA ROMEXIS (K140713)Planmeca Oy2014-06-16
EMBRYOGEN (K140317)Origio A/S2014-06-16
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE (K140134)Starboard Medical, LLC2014-06-16
PILLING ESOPHAGEAL BOUGIES (K133439)Teleflexmedical, Inc.2014-06-16
VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR (K140708)STERIS Corporation2014-06-16
OTC EMS STIMULATOR (K133965)Shenzhen Dongdixin Technology Co., Ltd.2014-06-16
REPROCESSED HARMONIC SHEAR (K132566)Sterilmed, Inc.2014-06-14
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION (K132524)Philips Medical Systems2014-06-13
DENTAL IMPLANT SYSTEM (K122807)Hager& Meisinger GmbH2014-06-13
KALARE (K133553)Toshiba America Medical Systems, In.C2014-06-13
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM (K140312)Edwards Lifesciences, LLC2014-06-13
ALERE I INFLUENZA A & B (K141520)Alere Scarborough, Inc D/B/A Binax, Inc.2014-06-13
LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) (K141055)Lin-Zhi International, Inc.2014-06-13
PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE (K131080)Reimers and Janssen GmbH2014-06-13
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) (K140462)Synthes (USA) Products, LLC2014-06-13
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K140960)Hologic, Inc.2014-06-13
MR ELASTOGRAPHY (K140666)Philips Medical Systems Nederland B.V.2014-06-13
U2 FEMORAL COMPONENT, CR, POROUS COATED (K140075)United Orthopedic Corp.2014-06-13
WINX SLEEP THERAPY SYSTEM (K132003)Apnicure, Inc.2014-06-13
SU-POR SURGICAL IMPLANT (K140437)Poriferous, LLC2014-06-13
IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST (K132978)Sequenom, Inc.2014-06-13
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL (K140759)Medos International SARL2014-06-13
ACUMED HAND FRACTURE SYSTEM (K141383)Acumed, LLC2014-06-13
SENYINT PACS (K133098)Dalian Senyint Digital Medical System Co., Ltd.2014-06-13
ONCENTRA BRACHY (K132816)Nucletron B.V.2014-06-13
BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM (K133884)Biodenta Swiss AG2014-06-13
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM (K133661)Earlysense, Ltd.2014-06-13
CELERITY SYSYEM (K140799)Medcomp (Medical Components, Inc.)2014-06-13
740 SELECT (K140430)Cas Medical Systems, Inc.2014-06-13
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE (K140695)Medtronic, Inc.2014-06-12
VIAL2BAG DIRECT CONNECT (K140730)Medimop Medical Projects, Ltd.2014-06-12
ZHAOFENG (K140240)Zhaofeng Glove Co., Ltd.2014-06-12
TERUMO SURFLO I.V. CATHETER (K133280)Terumo (Philippines) Corporation2014-06-12
TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE (K141306)Teva Medical Ltd., Migada Plant2014-06-12
WHITE VINYL EXAM GLOVES POWDER FREE (K140322)Shandong Dawei Medical Products Co., Ltd.2014-06-12
META-C CERVICAL PLATE (K140361)Medacta International2014-06-12
DURADIAGNOST (K141381)Philips Healthcare (Suzhou) Co., Ltd.2014-06-12
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG (K132375)Genicon2014-06-12
TRIPLEPLAY PRO (K141360)Wildcat Medical, Inc.2014-06-12
AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE (K141233)Medtronic, Inc.2014-06-12
FEIYUE (K140242)Feiyue Glove Co., Ltd.2014-06-12
WARTIE WART REMOVER (K140314)Yonmedical BV2014-06-12
JIAWANG (K140239)Jiawang Glove Co., Ltd.2014-06-12
DIGITAL ELECTROCARDIOGRAPH (K131858)Guangdong Biolight Meditech Co., Ltd.2014-06-11
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM (K141250)KARL STORZ Endoscopy-America, Inc.2014-06-11
CELESTEION, PCA-9000A/2 (K140651)Toshibamedical Systems Corporation2014-06-11
JO PREMIUM PERSONAL LUBRICANT (K132954)United Consortium2014-06-11
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS (K133403)Firestone Optics, Inc.2014-06-11
INTRA-OPERATIVE ULTRASOUND TRANSDUCER (K140854)Hitachi Aloka Medical, Ltd.2014-06-11
OPTICAL BIOMETER AL-SCAN (K133132)Nidek Co., Ltd.2014-06-11
CONTRAST MODULATION SYSTEM (K140425)Osprey Medical, Inc.2014-06-11
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