FDA 510(k) clearances — page 385

176,542 clearances on record, most recent first.

Clearances — page 385

38,401–38,500 of 176,542

K140132 — BIODENTINESeptodont·Product code KIF·2014-06-27
K140289 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSummit Medical, Inc.·Product code KCT·2014-06-27
K140542 — NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANERRhinosystems, Inc.·Product code KMA·2014-06-27
K140650 — HIVOX ELECTRIC STIMULATOR OTC TENSHivox Biotek, Inc.·Product code NUH·2014-06-27
K140701 — NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUGNovosource, Inc.·Product code OQG·2014-06-27
K140788 — P-STIMBiegler GmbH·Product code BWK·2014-06-27
K140819 — SURGICAL NAVIGATION ADVANCED PLATFORMSurgical Theater, LLC·Product code LLZ·2014-06-27
K140823 — PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDERVarian Medical Systems, Inc.·Product code IYE·2014-06-27
K141179 — A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITORA & D Co., Ltd.·Product code DXN·2014-06-27
K141413 — CRC PC WITH SMART CHAMBERCapintec, Inc.·Product code KPT·2014-06-27
K141428 — MDMC-12133Barco N.V.·Product code PGY·2014-06-27
K141578 — DEVON CIRONA 6200 DVTDevon Medical·Product code JOW·2014-06-27
DEN130034 — REWALKArgo Medical Technologies, Inc.·Product code PHL·2014-06-26
K133194 — DIAMOND RATTLESNAKE SYSTEMEminent Spine·Product code KWQ·2014-06-26
K133465 — CONSURE STOOL MANAGEMENT SYSTEMConsure Medical Pvt , Ltd.·Product code KNT·2014-06-26
K133579 — MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPSPontis Orthopaedics, LLC·Product code MBI·2014-06-26
K133961 — SURESIGNS VS3, SURESIGNS VS4Philips Medical Systems·Product code DSJ·2014-06-26
K140053 — KANGLI PEDICLE SCREW SPINAL SYSTEMSuzhou Kangli Orthopaedics Instrument Co., Ltd.·Product code MNH·2014-06-26
K140435 — MEDLEY GOLDAmerican Dental Sleep Medicine, Ip, LLC·Product code LRK·2014-06-26
K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSStryker Corporation·Product code FXY·2014-06-26
K140659 — COROENT THORACOLUMBAR IMPLANTSNu Vasive, Incorporated·Product code MAX·2014-06-26
K140803 — LUNERAY; CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMNucletron B.V.·Product code JAQ·2014-06-26
K141002 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMVisionsense, Ltd.·Product code HRX·2014-06-26
K141346 — SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991ADSony Electronics, Inc.·Product code LMC·2014-06-26
K141376 — INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSNexxt Spine, LLC·Product code MNH·2014-06-26
K141397 — SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEMPrecision Spine, Inc.·Product code MNI·2014-06-26
K141454 — SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MDSony Electronics, Inc.·Product code LMC·2014-06-26
K132115 — ABSOLUTE DENTIN 2Parkell, Inc.·Product code EBF·2014-06-25
K132180 — IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEMIdeal Life, Inc.·Product code NBW·2014-06-25
K132333 — BONDILOXS TOPICAL HEMOSTATIC DRESSINGMedtrade Products , Ltd.·Product code QSY·2014-06-25
K133327 — SATURNO(TM) OVERDENTURE IMPLANT SYSTEMZest Anchors, LLC·Product code DZE·2014-06-25
K133848 — RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWKHeartvista, Inc.·Product code LNH·2014-06-25
K140188 — MASIMO ROOT MONITORING SYSTEMMasimo Corporation·Product code MWI·2014-06-25
K140336 — OPTIMUS FUSION: SLT, YAG AND YAG/SLTQuantel Medical·Product code HQF·2014-06-25
K140629 — VENUS SWAN(MP)2Venus Concept , Ltd.·Product code GEI·2014-06-25
K140801 — VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEMBio-Rad Laboratories, Inc.·Product code LCP·2014-06-25
K141104 — TRUKLEAR BRACKETAjw Technology Consultants, Inc.·Product code NJM·2014-06-25
K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SETDiazyme Laboratories·Product code DBF·2014-06-24
K133105 — BREEZE NEBULIZER (NBR-10X)Digio2 International Co., Ltd.·Product code CAF·2014-06-24
K133816 — IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIALSiemens Healthcare Diagnostics, Inc.·Product code JJX·2014-06-24
K140660 — MOBIUS3DMobius Medical Systems, LP·Product code IYE·2014-06-24
K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METERBayer Healthcare, LLC·Product code NBW·2014-06-23
K131416 — NOVOPRESSMilka, LLC·Product code JOW·2014-06-23
K133193 — RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)Riverstone Resources Sdn Bhd·Product code LZA·2014-06-23
K140809 — CLIQ DV-300 ASPIRATORDing Hwa Co., Ltd.·Product code JCX·2014-06-23
K141072 — SUPOLENEResorba Medical GmbH·Product code GAT·2014-06-23
K141073 — LIQUICHEK TUMOR MARKER CONTROLBio-Rad Laboratories·Product code JJY·2014-06-23
K141232 — APTUS ULNA SHORTENING 2.5Medartis AG·Product code HRS·2014-06-23
K123149 — SERVO-I VENTILATOR SYSTEMMaquet Critical Care AB·Product code CBK·2014-06-20
K132489 — INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)Inogen, Inc.·Product code CAW·2014-06-20
K132697 — ENCOMPASS 10/12 HIP STEMOrtho Development Corp.·Product code LPH·2014-06-20
K133011 — DIAPHRAGMATIC HERNIA GRAFTCook Biotech, Inc.·Product code OWV·2014-06-20
K133062 — DISCOVERY SYSTEMInnovative Visual Systems·Product code HJO·2014-06-20
K133147 — BRACCO INJEENERING TRANSFER SETBracco Injeneering S.A.·Product code PQH·2014-06-20
K133646 — ADMIRESiemens Medical Systems, Inc.·Product code JAK·2014-06-20
K133799 — THERMEDX FLUID MANAGMENT SYSTEMThermedx, LLC·Product code HIG·2014-06-20
K133886 — PERSEUS A500Draeger Medical GmbH·Product code BSZ·2014-06-20
K134032 — ULTHERA SYSTEMUlthera, Inc.·Product code OHV·2014-06-20
K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)Nanosphere, Inc.·Product code PCH·2014-06-20
K140155 — SECURE-GARD SURGICAL AND PROCEDURE FACE MASKCardinal Health200, LLC·Product code FXX·2014-06-20
K140278 — SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXSomnomed, Inc.·Product code LRK·2014-06-20
K140610 — NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)Hartalega NGC Sdn. Bhd.·Product code LZA·2014-06-20
K140679 — SUREFLEX LITHOTRIPSY LASER FIBERSAmerican Medical Systems·Product code GEX·2014-06-20
K140711 — COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,Paragon Bioteck, Inc.·Product code LZU·2014-06-20
K141121 — AXSOS 3 TI LOCKING PLATE SYSTEMStryker Trauma AG·Product code HRS·2014-06-20
K141149 — VITEK 2 AST GP CEFTAROLINEbioMerieux, Inc.·Product code LON·2014-06-20
K141199 — QUENTRY DOSE REVIEWBrainlab AG·Product code LLZ·2014-06-20
K141204 — VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEMStryker Trauma AG·Product code HRS·2014-06-20
K141329 — RADSPATelerad Tech Private Limited·Product code LLZ·2014-06-20
K141356 — ECHO TIP ULTRA FIDUCIAL NEEDLEWilson-Cook Medical, Inc.·Product code NEU·2014-06-20
K130694 — JR IMPLANT SYSTEMLK Consulting Group USA, Inc.·Product code DZE·2014-06-19
K132869 — SILDENTHrs Co., Ltd.·Product code ELW·2014-06-19
K132891 — HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVERThe Hymed Group Corp.·Product code FRO·2014-06-19
K133087 — ABBVIE PEGAbbVie , Inc.·Product code KNT·2014-06-19
K133129 — ABBVIE NJAbbVie , Inc.·Product code KNT·2014-06-19
K133258 — TRUFREEZE SYSTEMCSA Medical, Inc.·Product code GEH·2014-06-19
K140370 — DISPOSABLE PRESSURE MANOMETERBesmed Health Business Corp·Product code CAP·2014-06-19
K140510 — MIROMATRIX WOUND MATRIXMiromatrix Medical, Inc.·Product code KGN·2014-06-19
K140644 — PROCEMOtotronix, LLC·Product code NEA·2014-06-19
K140678 — COSMOLOCK PEDICLE SCREW SYSTEMKalitec Direct, LLC·Product code MNH·2014-06-19
K140937 — OSSEOFLEX SBOsseon, LLC·Product code NDN·2014-06-19
K130581 — KONIX STERILE GELTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa·Product code MUI·2014-06-18
K130733 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Benteng Plastic Co., Ltd.·Product code LYZ·2014-06-18
K133096 — ABB VIE JAbbVie , Inc.·Product code KNT·2014-06-18
K133295 — QUALISMenicon Co., Ltd. New Business Division·Product code MQK·2014-06-18
K140067 — QARDIOARMQardio, Inc.·Product code DXN·2014-06-18
K140583 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIESGrandway Technology (Shenzhen) Limited·Product code DXN·2014-06-18
K141029 — TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMTornier, Inc.·Product code PHX·2014-06-18
K141313 — REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEMReverse Medical Corporation·Product code KRD·2014-06-18
K141363 — CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETERMerit Medical Systems, Inc.·Product code MSD·2014-06-18
K132833 — ULTRA RENEW PLUSAccord Media·Product code OLP·2014-06-17
K133635 — EASYPOINT NEEDLERetractable Technologies, Inc.·Product code FMI·2014-06-17
K140159 — S9 WANDA VPAP STResmed, Ltd.·Product code BZD·2014-06-17
K140441 — BI-FLEX URETERAL ACCESS SHEATHPromepla Sam·Product code KNY·2014-06-17
K140450 — KEELER KAPTURE SOFTWAREKeeler Limited·Product code HKI·2014-06-17
K132289 — GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEMGemss Medical Systems Co., Ltd.·Product code JAA·2014-06-16
K133439 — PILLING ESOPHAGEAL BOUGIESTeleflexmedical, Inc.·Product code FAT·2014-06-16
K133965 — OTC EMS STIMULATORShenzhen Dongdixin Technology Co., Ltd.·Product code NGX·2014-06-16
K140006 — ENDOSHIELD BURN PROTECTION SYSTEMEncision, Inc.·Product code GEI·2014-06-16
K140073 — U2 FEMORAL COMPONENT, CR, CEMENTEDUnited Orthopedic Corp.·Product code JWH·2014-06-16

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