FDA 510(k) clearances — page 440

176,542 clearances on record, most recent first.

Clearances — page 440

43,901–44,000 of 176,542

K120235 — MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTPAerolase Medical Lasers, LLC·Product code GEX·2012-09-17
K120281 — DIGNITY POWER INJECTABLE TITANIUM PORTMedical Components, Inc.·Product code LJT·2012-09-17
K120328 — ORIGINS LIPOHARVESTING SYSTEMSound Surgical Technologies, LLC·Product code MUU·2012-09-17
K121022 — AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIVAmeriwater·Product code FIP·2012-09-17
K121114 — TIGRAN PERIBRUSHTigran Technologies AB·Product code ELB·2012-09-17
K121187 — KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBESKatalyst Surgical, LLC·Product code HQF·2012-09-17
K122487 — BIOFIBER SYTURETornier, Inc.·Product code NWJ·2012-09-17
K122506 — SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESSSurefire Medical, Inc.·Product code DQX·2012-09-17
K100645 — AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACEMedtronic, Inc.·Product code DTZ·2012-09-14
K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KITSmiths Medical Asd, Inc.·Product code CAZ·2012-09-14
K111375 — STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATORAdvanced Sterilization Products·Product code FRC·2012-09-14
K113296 — ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMERZimmer, Inc.·Product code LPH·2012-09-14
K120825 — SUPRA SCAN DELIVERY SYSTEMQuantel Medical·Product code HQF·2012-09-14
K121153 — PEEK CUSTOMIZED CRAIAL IMPLANT KITStryker·Product code GWO·2012-09-14
K121439 — METAFIX FEMORAL HIP STEM SIZE 1Corin USA·Product code LZO·2012-09-14
K121575 — OXFORD ANKLE FUSION NAIL(AFN) SYSTEMOrtho Solutions Limited·Product code HSB·2012-09-14
K121625 — LULLABY TM WARMERWipro GE Healthcare Private, Ltd.·Product code FMT·2012-09-14
K121694 — IMAGER II ANGIOGRAPHIC CATHETERBoston Scientific Corp·Product code DQO·2012-09-14
K111128 — LABONACHECK A1CCeragem International, Inc.·Product code LCP·2012-09-13
K111377 — STERRAD(R) 100NX STERILIZER DUO CYCLEAdvanced Sterilization Products·Product code MLR·2012-09-13
K112741 — POWDER FREE VINYL PATIENT EXAMINATION GLOVELifestyle Safty Products (Hui Zhou) Co., Ltd.·Product code LYZ·2012-09-13
K113725 — VIRTUOSTO.N. Diagnostics·Product code KGI·2012-09-13
K113841 — IMMUNOCAP ALLERGEN COMPONENTS BUNDLEPhadia US, Inc.·Product code DHB·2012-09-13
K120737 — TRIA LASER HAIR REMOVAL SYSTEMTria Beauty, Inc.·Product code GEX·2012-09-13
K121078 — VAN GOGH ANTERIOR CERVICAL PLATE SYSTEMAccel Spine·Product code KWQ·2012-09-13
K121335 — G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVEHutchinson Sante S.N.C.·Product code KGO·2012-09-13
K121479 — AIMInneroptic Technology, Inc.·Product code IYO·2012-09-13
K121541 — JAZZ SYSTEMImplanet, S.A.·Product code JDQ·2012-09-13
K121774 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUSBoston Scientific Corp·Product code MCW·2012-09-13
K121827 — GSI VIEWER WITH VUE OPTIONGE Medical Systems SCS·Product code JAK·2012-09-13
K122019 — STREPTOCOCCUS APP. SEROLOGICAL REAGENTSMeridian Bioscience, Inc.·Product code OYZ·2012-09-13
K122119 — DX-D FULL LEG FULL SPINEAfga Healthcare N.V.·Product code KPR·2012-09-13
K122413 — PATIENT POSITIONING SYSTEMForte Automation Systems, Inc.·Product code JAI·2012-09-13
K122491 — VIAMO SSA-640A V4.0Toshibamedical Systems Corporation·Product code IYN·2012-09-13
K122579 — VELASHAPESyneron Medical, Ltd.·Product code NUV·2012-09-13
K122593 — PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2Optim, LLC·Product code FEH·2012-09-13
K112693 — NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVESSgmp Co., Ltd.·Product code LYY·2012-09-12
K120277 — VITAL COUGHLung Assist, Inc.·Product code NHJ·2012-09-12
K120384 — PROTECTOR, INJECTOR, CONNECTORBd Medical-Medical Surgical Systems·Product code LHI·2012-09-12
K121112 — STRYKER VIDEO URETEROSCOPEStryker Endoscopy·Product code FGB·2012-09-12
K121256 — ALCO-SCREEN 02Chematics, Inc.·Product code DIC·2012-09-12
K122260 — AYCAN MOBILEAycan Digitalsysteme GmbH·Product code LLZ·2012-09-12
K122427 — CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARECarestream Dental, LLC·Product code LLZ·2012-09-12
K122569 — LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR3M Company·Product code EBF·2012-09-12
K112221 — EUROIMMUN ANTI-SLA/LP ELISA(LGG)Euroimmun US·Product code NIY·2012-09-11
K112223 — EUROIMMUN ANTI-LKM-1 ELISA(LGG)Euroimmun US·Product code NBS·2012-09-11
K113393 — POWDER FREE BLACK NITRILE EXAMINATION GLOVESTg Medical Sdn. Bhd.·Product code LZA·2012-09-11
K120009 — TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)Abbott Laboratories·Product code CDZ·2012-09-11
K120012 — INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTSIntegra LifeSciences Corporation·Product code GCJ·2012-09-11
K120766 — ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)Prosurg, Inc.·Product code FAJ·2012-09-11
K120776 — ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTIONBiomet 3i·Product code NHA·2012-09-11
K121492 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENTBeckman Coulter, Inc.·Product code LCP·2012-09-11
K121528 — POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLORShen Wei (Usa), Inc.·Product code LZA·2012-09-11
K121630 — RANGE SPINAL SYSTEMK2m, Inc.·Product code OSH·2012-09-11
K121801 — QUINTEX CERVICAL PLATING SYSTEMAesculap Implant Systems, LLC·Product code KWQ·2012-09-11
K122352 — NUVASIVE PRECEPT SPINAL SYSTEMNuvasive, Inc.·Product code NKB·2012-09-11
K122387 — VOLUSON P6, VOLUSON P8GE Healthcare·Product code IYN·2012-09-11
K122462 — ROTH NET RETRIEVERUnited States Endoscopy Group, Inc.·Product code FDI·2012-09-11
K122471 — SOMATOM DEFINITIONSiemens Medical Systems, Inc.·Product code JAK·2012-09-11
K122515 — C2-9-D ULTRASOUND TRANSDUCERGE Healthcare·Product code ITX·2012-09-11
K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5Roche Diagnostics·Product code OIU·2012-09-10
K113060 — UNITY TOATAL KNEE SYSTEMCorin USA·Product code JWH·2012-09-10
K113731 — ESENSOR RESPIRATORY VIRAL PANELClinical Micro Sensors, Inc.·Product code JJH·2012-09-10
K120126 — BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIEBarosense, Inc.·Product code FED·2012-09-10
K120924 — BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUGCorentec Co., Ltd.·Product code LPH·2012-09-10
K121273 — VISIONS PV .035 DITITAL IVUS CATHETERVolcano Corporation·Product code OBJ·2012-09-10
K121316 — LANX SPINAL FIZATION SYSTEMLanx, Inc.·Product code NKB·2012-09-10
K121372 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORAndon Health Co, Ltd.·Product code DXN·2012-09-10
K121573 — INTEGRA CAMINO ICP MONITORIntrgra Lifesciences Corporation·Product code GWM·2012-09-10
K121822 — DELICOTAmerican Surgical Company, LLC·Product code HBA·2012-09-10
K121885 — EARLYSENSE CENTRAL DISPLAY SYSTEMEarlysense, Ltd.·Product code MSX·2012-09-10
K121935 — TAPERSET HIP SMALL STEMSConsensus Orthopedics, Inc.·Product code LPH·2012-09-10
K121947 — ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVESNorthstar Healthcare Holdings·Product code LZA·2012-09-10
K122363 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUESiam Sempermed Corp., Ltd.·Product code LZA·2012-09-10
K122498 — MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)Hologic, Inc.·Product code HIH·2012-09-10
K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXXMaquet Cardiovascular, LLC·Product code MAL·2012-09-10
K113407 — SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORSCarefusion 2200, Inc.·Product code GEI·2012-09-07
K113761 — INFRARED THERMOMETERFamidoc Technology Co., Ltd.·Product code FLL·2012-09-07
K113821 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMTransonic Systems, Inc.·Product code DXG·2012-09-07
K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.·Product code LBS·2012-09-07
K120685 — ZYNO MEDICAL ADMINISTRATION SETZyno Medical, LLC·Product code FPA·2012-09-07
K120875 — B&W DENTAL IMPLANT SYSTEMB&W Srl·Product code DZE·2012-09-07
K121228 — PONTO BONE ANCHORED HEARING SYSTEMOticon Medical AB·Product code MAH·2012-09-07
K121353 — MINI PATCHWell-Life Healthcare Limited·Product code NUH·2012-09-07
K121366 — HEMOCUE HBA1C 501Infopia Co, Ltd.·Product code LCP·2012-09-07
K121641 — MINIARC PRO SINGLE-INCISION SLING SYSTEMAmerican Medical Systems·Product code PAH·2012-09-07
K121714 — SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSSmith & Nephew, Inc.·Product code HSD·2012-09-07
K121749 — VERACIAShofu Dental Corporation·Product code ELM·2012-09-07
K121797 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BBecton, Dickinson and Company·Product code PSZ·2012-09-07
K121914 — MASIMO SET USPO2 PULSE OXIMETRY CABLEMasimo Corporation·Product code DQA·2012-09-07
K121941 — ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.)·Product code LJS·2012-09-07
K121983 — DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRABenq Medical Technology Corpation·Product code IYN·2012-09-07
K122136 — VITREAVIEWVital Images, Inc.·Product code LLZ·2012-09-07
K122164 — MR VESSELLQ XPRESSGE Medical Systems SCS·Product code LLZ·2012-09-07
K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.·Product code DTL·2012-09-07
K112200 — FOCUS TOUCH CONCEPTION SYSTEMIntimate Bridge 2 Conception, Inc.·Product code OBB·2012-09-06
K112892 — IMPELLA 2.5 PLUS CATHETERAbiomed, Inc.·Product code PBL·2012-09-06
K113648 — LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELFAap Implantate AG·Product code HRS·2012-09-06
K120730 — LOUTREX TOPICAL CREAMAcella Pharmaceuticals, LLC·Product code FRO·2012-09-06
K120732 — LENSSX LASER SYSTEMAlcon Lensx, Inc.·Product code HQC·2012-09-06

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