FDA 510(k) clearances — page 416

176,542 clearances on record, most recent first.

Clearances — page 416

41,501–41,600 of 176,542

K131081 — CYBER TM FAMILYQuanta System Spa·Product code GEX·2013-07-03
K131090 — 2MP COLOR LCD MONITOR, RADIFORCE MX215Eizo Corporation·Product code LLZ·2013-07-03
K131106 — DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,Canon, Inc.·Product code MQB·2013-07-03
K131474 — ARTHREX DISTAL RADIUS PLATE SYSTEMArthrex, Inc.·Product code HRS·2013-07-03
K131480 — EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEMEmerge Medical·Product code HRS·2013-07-03
K131573 — CP150 ELECTROCARDIOGRAPHWelch Allyn, Inc.·Product code DPS·2013-07-03
K131575 — EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHTExactech, Inc.·Product code PHX·2013-07-03
K131670 — LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)Biomet, Inc.·Product code HRS·2013-07-03
K131786 — AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTERAirstrip Technologies, LP·Product code MWI·2013-07-03
K122652 — ARTHROCARE TURBINATOR WANDArthroCare Corporation·Product code GEI·2013-07-02
K123803 — REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEMReverse Medical Corporation·Product code KRD·2013-07-02
K130256 — MDK MULTI-APPLICATIONS PLATFORMQuanta System Spa·Product code GEX·2013-07-02
K130350 — PROCELLERAVomaris Innovations, Inc.·Product code FRO·2013-07-02
K130919 — SENSUSNeurometrix, Inc.·Product code GZJ·2013-07-02
K130920 — CORRECT PLUS 1Pentron Clinical·Product code ELW·2013-07-02
K130935 — DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCARayence Co., Ltd.·Product code MQB·2013-07-02
K131002 — VIDA PTV DILATATON CATHETERC.R. Bard, Inc.·Product code OMZ·2013-07-02
K131035 — Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec·Product code MBI·2013-07-02
K131238 — AFFIX SPINOUS PROCESS PLATE SYSTEMNuvasive, Inc.·Product code PEK·2013-07-02
K131372 — MOBIS IISignus Medizintechnik GmbH·Product code MAX·2013-07-02
K131401 — BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETERMercator Medsystems, Inc.·Product code EOQ·2013-07-02
K122202 — ELLEX 2RTEllex Medical Pty, Ltd.·Product code HQF·2013-07-01
K124030 — COOK HOLMIUM LASER FIBERCook Incorporated·Product code GEX·2013-07-01
K130300 — HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AG·Product code DWC·2013-07-01
K130353 — PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)Pipeline Orthopedics·Product code LPH·2013-07-01
K130408 — ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENTSterngold Dental, LLC·Product code NHA·2013-07-01
K131705 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGYCovidien, Formerly US Surgical A Divison of Tyco H·Product code GDW·2013-07-01
K131743 — CIRONA DVT FOOT GARMENTDevon Medical, Inc.·Product code JOW·2013-07-01
K122917 — CODA BALLOON CATHETERCook, Inc.·Product code DQY·2013-06-28
K123275 — IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOMPhadia AB·Product code DHB·2013-06-28
K123354 — REVITIVE IXActegy , Ltd.·Product code IPF·2013-06-28
K123427 — NIRVANA D PERSONAL LUBRICANT (TBD)Church & Dwight Co., Inc.·Product code NUC·2013-06-28
K123559 — SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEMBiotest Medical Corp.·Product code NBW·2013-06-28
K123598 — SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·Product code JDI·2013-06-28
K123627 — ET SMARTFIT ABUTMENTHiossen, Inc.·Product code NHA·2013-06-28
K130002 — SURECALL LABOR MONITORReproductive Research Technologies, LP·Product code OSP·2013-06-28
K130638 — ALLURACLARITY XPER FD SERIES X-RAY SYSTEMPhilips Medical Systems Nederland B.V.·Product code OWB·2013-06-28
K130724 — CODIAGNOSTIX IMPLANT PLANNING SOFTWAREStraumann USA·Product code LLZ·2013-06-28
K130808 — STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWSStraumann USA·Product code NHA·2013-06-28
K131509 — ZOE FLUID STATUS MONITORNoninvasive Medical Technologies, Inc.·Product code DSB·2013-06-28
K131568 — SUDO PATHLd Technology, LLC·Product code GZO·2013-06-28
K131619 — QUICKVUE INFLUENZA A+BQuidel Corp.·Product code GNX·2013-06-28
K121920 — LASERBRUSHSunetics International Marketing Group, LLC·Product code OAP·2013-06-27
K123404 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)Becton, Dickinson & CO·Product code LON·2013-06-27
K130094 — FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMAbbott Diabetes Care·Product code NBW·2013-06-27
K130438 — AXLE INTERSPINOUS FUSION SYSTEMX-Spine Systems, Inc.·Product code PEK·2013-06-27
K130790 — LYRIC2Phonak, LLC·Product code ESD·2013-06-27
K131100 — STREAMLINE TL SPINAL SYSTEMPioneer Surgical Technology, Inc.·Product code NKB·2013-06-27
K131141 — EARPROBEPath Medical GmbH·Product code GWJ·2013-06-27
K131589 — KEELER SLIT LAMP H-SERIESKeeler, Ltd.·Product code HJO·2013-06-27
K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERSenorx, Inc.·Product code NEU·2013-06-27
K131683 — HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company·Product code MBI·2013-06-27
K122653 — MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIESKimberly-Clark Corporation·Product code KNT·2013-06-26
K122983 — KSEA BIPOLAR ELECTRODEKARL STORZ Endoscopy-America, Inc.·Product code HIN·2013-06-26
K122997 — 23GA CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.·Product code HQB·2013-06-26
K123266 — BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GNBecton, Dickinson and Company·Product code LON·2013-06-26
K123288 — HEMOCONCENTRATORMaquet Cardiopulmonary, AG·Product code KDI·2013-06-26
K130549 — INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORCarl Zeiss Meditec, Inc.·Product code JAD·2013-06-26
K130584 — MONITOR B40Ge Medical Systems China Co., Ltd.·Product code MHX·2013-06-26
K131556 — DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETDiazyme Laboratories·Product code JIT·2013-06-26
K121481 — INFINI RADIOFREQUENCY SYSTEMLutronic Corporation·Product code GEI·2013-06-25
K121628 — EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)Epi Mobile Health Solutions (S) Pte, Ltd.·Product code DXH·2013-06-25
K122503 — PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOONNeuro Therm, Inc.·Product code NDN·2013-06-25
K130008 — DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKINGI.T.S. GmbH·Product code HRS·2013-06-25
K130487 — FASTRESPONDER STERNAL INTRAOSSEOUS DEVICEPyng Medical Corp.·Product code FMI·2013-06-25
K130850 — PRIMI AND SECONDI SUPPORT CATHETERSThermopeutix, Inc.·Product code DQY·2013-06-25
K131005 — EBA2 FEMORAL NAILING SYSTEMCitieffe S.R.L.·Product code HSB·2013-06-25
K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.·Product code LCM·2013-06-25
K131314 — DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)Swissray Medical AG·Product code MQB·2013-06-25
K131373 — SHANGRINGWuhu Snnda Medical Treatment Appliance Technology·Product code HFX·2013-06-25
K131489 — TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATIONTractus Corporation·Product code IYO·2013-06-25
K123842 — LAWMAX DILATORLifetech Scientific (Shenzhen) Co., Ltd.·Product code DRE·2013-06-24
K131092 — STEALTH 360 ORBITAL PAD SYSTEMCardio Systems, Inc.·Product code MCW·2013-06-24
K131287 — CARDIOSLEEVERijuven Corp·Product code DQD·2013-06-24
K131524 — PROTEUS PATCH INCLUDING INGESTIBLE SENSORProteus Digital Health, Inc.·Product code OZW·2013-06-23
K120727 — MFM-CMS CENTRAL MONITORING SYSTEMEdan Instruments, Inc.·Product code MHX·2013-06-21
K122957 — TEZO TITANIUM CAGE FAMILYUlrich GmbH & Co. KG·Product code MAX·2013-06-21
K123158 — ION MAGNUM GENIUSIon Genius, Inc.·Product code NGX·2013-06-21
K124038 — BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)Bedside Clinical Systems, Inc.·Product code MWI·2013-06-21
K130099 — TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019Encore Medical L.P.·Product code LPH·2013-06-21
K130281 — OAK RIDGE PRODUCTS SHARP CONTAINEROak Ridge Products, LLC·Product code MMK·2013-06-21
K130295 — LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.Infopia Co, Ltd.·Product code NBW·2013-06-21
K130310 — CERTAIN BELLATEK PROVISIONAL ABUTMENTSBiomet 3i·Product code NHA·2013-06-21
K130664 — HYRDROMAX HMEFA-M Systems·Product code CAH·2013-06-21
K130816 — INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)Neuro Resource Group, Inc.·Product code GXY·2013-06-21
K130833 — DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYN·2013-06-21
K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBiofire Diagnostics, Inc.·Product code PEN·2013-06-21
K131131 — E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEMIntromedic Co., Ltd.·Product code EOX·2013-06-21
K131213 — DIGITAL COLOR DOPPLER ULTRASOUND SYSTEMSonoscape Company Limited·Product code IYN·2013-06-21
K131288 — VERRATA PRESSURE GUIDE WIREVolcano Corporation·Product code DQX·2013-06-21
K112598 — AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)American Surgical Company, LLC·Product code HBA·2013-06-20
K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KITAstoria-Pacific, Inc.·Product code JIA·2013-06-20
K122763 — PHYSIOLOGICAL DATA PROCESSORZephyr Technology Corporation·Product code DRG·2013-06-20
K123106 — DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60ASamsung Electronics Co., Ltd.·Product code KPR·2013-06-20
K130217 — ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEMOrthoPediatrics Corp.·Product code MBI·2013-06-20
K130279 — REFORM PEDICLE SCREW SYSTEMSpinal USA·Product code MNI·2013-06-20
K130397 — ARROW GPSCATH BALLOON DILATATION CATHETERHotspur Technologies·Product code LIT·2013-06-20
K130486 — FUTURABOND UNIVERSALVoco GmbH·Product code KLE·2013-06-20
K130722 — AIRCAST VENAFLOW ELITE SYSTEMDjo, LLC·Product code JOW·2013-06-20
K130794 — CELLTRACKS ANALYZER II SYSTEMVeridex, LLC·Product code NQI·2013-06-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.