FDA 510(k) clearances — page 452

176,542 clearances on record, most recent first.

Clearances — page 452

45,101–45,200 of 176,542

K113341 — GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEMHitachi Medical Systems America, Inc.·Product code JAK·2012-05-03
K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICALCryotherapy Products, Inc.·Product code LKX·2012-05-03
K113812 — ATAL-8Atlaim·Product code MQB·2012-05-03
K120335 — EMBRACE THERMOPLASTICBionix Development Corp.·Product code IYE·2012-05-03
K120344 — RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICERadiadyne, LLC (Specification Developer)·Product code JAQ·2012-05-03
K120351 — CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CAI-Sens, Inc.·Product code NBW·2012-05-03
K120359 — ORTHOLOC 3DI HALLUX SYSTEMWrightmedicaltechnologyinc·Product code HRS·2012-05-03
K120431 — HALO90 ULTRA ABLATION CATHETERBarrx Medical, Inc.·Product code GEI·2012-05-03
K120704 — 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM3M Company·Product code DRG·2012-05-03
K120768 — ES FLOWSpident Co., Ltd.·Product code EBF·2012-05-03
K121006 — ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETERSt Jude Medical·Product code MTD·2012-05-03
K121020 — VIPER SYSTEMDepuy Spine, Inc.·Product code NKB·2012-05-03
K121037 — LOSPA TIBIAL BASE PLATECorentec Co., Ltd.·Product code JWH·2012-05-03
K121182 — VIALOK NON-VENTEDYukon Medical, LLC·Product code LHI·2012-05-03
K121194 — ENDO CLIP III 5MM CLIP APPLIERCovidien·Product code FZP·2012-05-03
K111008 — MICROWARE BONE PLATES AND BONE SCREWMicroware Precision Co., Ltd.·Product code HRS·2012-05-02
K112288 — JIAJIAN TENSWuxi Jiajian Medical Instrument Co., Ltd.·Product code GZJ·2012-05-02
K112924 — RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAMERiverstone Resources Sdn Bhd·Product code LZA·2012-05-02
K113088 — HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)Innerspace, Inc.·Product code GWM·2012-05-02
K113355 — POSEY BEDJ. T. Posey Co.·Product code OYS·2012-05-02
K113511 — ECHOSTAR SPICA 1.5T MR SYSTEMAlltech Medical Systems America, Inc.·Product code LNH·2012-05-02
K120023 — ZELTIQ COOLSCULPTINGZeltiq Aesthetics, Inc.·Product code OOK·2012-05-02
K120168 — LULLABY LED PHOTTHERAPY SYSTEMWipro GE Healthcare Private, Ltd.·Product code LBI·2012-05-02
K120184 — POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLOREDEncompass Medical Supplies Inc Limited·Product code LZA·2012-05-02
K120261 — PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBERPerouse Medical·Product code FPA·2012-05-02
K120438 — FLASH (DIFFERENT MATERIALS)3M Deutschland GmbH·Product code ELW·2012-05-02
K120978 — OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLARMerete Medical GmbH·Product code HSB·2012-05-02
K120980 — 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICCMedical Components, Inc.·Product code LJS·2012-05-02
K120981 — 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICCMedical Components, Inc.·Product code LJS·2012-05-02
K120983 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEMBoston Scientific Corporation·Product code ESW·2012-05-02
K121139 — ACCUMESH DEPLOYMENT SYSTEMCovidien, LLC·Product code ORQ·2012-05-02
K121167 — CAIRE COMPANION 5 OXYGEN CONCENTRATORCaire, Inc.·Product code CAW·2012-05-02
K110212 — INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIPAlere San Diego, Inc (Formally Biosite Incorporate·Product code GJS·2012-05-01
K111925 — PSYCHEMEDICS COCAINE EIAPsychemedics Corp.·Product code JXO·2012-05-01
K111926 — PSYCHEMEDICS OPIATES EIAPsychemedics Corp.·Product code DJG·2012-05-01
K111927 — PSYCHEMEDICS METHAMPHETAMINE EIAPsychemedics Corp.·Product code LAF·2012-05-01
K111928 — PSYCHEMEDICS PHENCYCLIDINE EIAPsychemedics Corp.·Product code LCM·2012-05-01
K111929 — PSYCHEMEDICS CANNABINOIDS EIAPsychemedics Corp.·Product code LDJ·2012-05-01
K112593 — STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMStryker Corporation·Product code ERL·2012-05-01
K112684 — MONT BLANC PEDICLE SCREW SYSTEMSQualgenix·Product code NKB·2012-05-01
K112801 — AYERS ROCK CERVICAL CAGEQualgenix·Product code ODP·2012-05-01
K112986 — LATERAL FUSION DEVICEIntegra Spine (Integra Lifesciences)·Product code MAX·2012-05-01
K113145 — ECHELON OVAL MRI SYSTEMHitachi Medical Systems America, Inc.·Product code LNH·2012-05-01
K113384 — EXTERNAL FIXATOR ST.A R 90 F4Citieffe·Product code KTT·2012-05-01
K113833 — VITAL SIGNS MONITORGuangdong Biolight Meditech Co., Ltd.·Product code MWI·2012-05-01
K120748 — SPEEDUP SOFTWARE OPTIONEsaote, S.p.A.·Product code LNH·2012-05-01
K121044 — ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIMMeridian Bioscience, Inc.·Product code NJR·2012-05-01
DEN110016 — PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTSEthicon Endo-Surgery·Product code OXT·2012-04-30
DEN120013 — PORTRAIT ANALYZERGreat Basin Scientific·Product code OMN·2012-04-30
K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROLHORIBA ABX SAS·Product code CGX·2012-04-30
K112148 — POWERED MUSCLE STIMULATORValmed, SA·Product code IPF·2012-04-30
K112909 — OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTIONBausch & Lomb, Inc.·Product code LPN·2012-04-30
K113687 — EQUINOX RELIEVEO-Two Medical Technologies, Inc.·Product code BZR·2012-04-30
K120215 — SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILEIntuitive Surgical, Inc.·Product code NAY·2012-04-30
K120492 — K2 MEDICAL VASCULAR CLAMPSK2 Medical GmbH & Co. KG·Product code DXC·2012-04-30
DEN100016 — PROSTATE MECHANICAL IMAGERArtann Laboratories, Inc.·Product code OQT·2012-04-27
K110629 — RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER3B Products, Inc.·Product code BZD·2012-04-27
K111250 — DRY MOUTH MOUTHWASHDr. Fresh, Inc.·Product code LFD·2012-04-27
K111895 — ECHOTIP(R) ULTRA FIDUCIAL NEEDLEWilson-Cook Medical Inc./Cook Endoscopy·Product code NEU·2012-04-27
K112314 — NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTERNephros, Inc.·Product code KDI·2012-04-27
K112535 — GENESIS REUSABLE RIGID CONTAINER SYSTEMCarefusion 2200, Inc.·Product code KCT·2012-04-27
K113119 — ENDOGATOR ADVANTAGE IRRIGATION PUMPByrne Medical, Inc.·Product code OCX·2012-04-27
K113221 — NAMSA BIOLOGICAL INDICATOR SPORE STRIPSNorth American Science Assoc., Inc.·Product code FRC·2012-04-27
K113286 — ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERSGe Medical Systems Lunar·Product code KGI·2012-04-27
K113599 — SURGICASE CONNECTMaterialise NV·Product code LLZ·2012-04-27
K113616 — ACCUDXA2Lone Oak Medical Technologies, LLC·Product code KGI·2012-04-27
K113707 — STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATINGCardinal Health-Medical Products and Services·Product code KGO·2012-04-27
K113837 — POWDER FREE VINYL PATIENT EXAMINATION GLOVESHebei Changsheng Plastic Products Co., Ltd.·Product code LYZ·2012-04-27
K113848 — R3 XLPE LINERSSmith & Nephew, Inc.·Product code MBL·2012-04-27
K120043 — CSM INTERNAL-R IMPLANT SYSTEMCsm Implant·Product code DZE·2012-04-27
K120108 — APTUS PROXIMAL HUMERUS SYSTEMMedartis AG·Product code HRS·2012-04-27
K120341 — PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MMVarian Medical Systems, Inc.·Product code JAQ·2012-04-27
K120741 — VOLUSON S6, VOLUSON S8GE Healthcare·Product code IYN·2012-04-27
K120746 — DISPOSABLE POWDER FREE VINYL EXAM GLOVESCanopus Medical Supply Co., Ltd.·Product code LYZ·2012-04-27
K120764 — EPIFLO(R)Neogenix, LLC·Product code KPJ·2012-04-27
K120935 — SECURACATHInterrad Medical, Inc.·Product code OKC·2012-04-27
K120962 — PATHASSIST LIGHT FIBEREntellus Medical, Inc.·Product code LRC·2012-04-27
K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLETSurgical Appliance Industries, Inc.·Product code DWL·2012-04-27
K110835 — GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSGEO MEDICAL CO., LTD.·Product code LPL·2012-04-26
K112153 — IROOT 100 MINIS-Denti Co., Ltd.·Product code LQY·2012-04-26
K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMConvatec, Inc.·Product code KNT·2012-04-26
K113796 — SOLITAIRE-C CERVICAL SPACER SYSTEMEbi, LLC·Product code OVE·2012-04-26
K120437 — TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEMBiolitec Sia (Latvia)·Product code GEX·2012-04-26
K120517 — DEPUY PULSE CERVICAL CAGE SYSTEMMedos International SARL·Product code ODP·2012-04-26
K120939 — AERONEB PROAerogen, Ltd.·Product code CAF·2012-04-26
K121070 — C-QUR RPM MESHAtrium Medical Corp.·Product code FTL·2012-04-26
K111085 — SHARPS TANK REUSABLE SHARPS CONTAINERRehrig Pacific Company·Product code MMK·2012-04-25
K112611 — SINTEA PLUSTEK PLS MULTI-AXIAL SCREWSSintea Plastek, LLC·Product code MNI·2012-04-25
K112761 — ZOLL PROPAQ MDZoll Medical Corporation, World Wide Headquarters·Product code MKJ·2012-04-25
K113485 — ELECTROCARDIOGRAPHShenzhen Carewell Electronics Co., Ltd.·Product code DPS·2012-04-25
K113585 — NASAL/EPISTAXIS PACKCogent Therapeutics, LLC·Product code LYA·2012-04-25
K113760 — VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICKHowmedica Osteonics Corp., Dba Stryker Orthopaedics·Product code HRS·2012-04-25
K120908 — HYDROCOIL EMBOLIC SYSTEM (HES)MicroVention, Inc.·Product code HCG·2012-04-25
K120979 — CAREFUSION NICOLET EDXCarefusion 209, Inc.·Product code GWF·2012-04-25
K103230 — AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTIONBestgen Biotech Corp.·Product code CGA·2012-04-24
K112094 — BRAIN BIOPSY NEEDLEAd-Tech Medical Instrument Corp·Product code HAW·2012-04-24
K112734 — APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.·Product code FIE·2012-04-24
K120015 — OSTEOMED WRIST PLATING SYSTEMOsteomed LP·Product code HRS·2012-04-24
K120055 — HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOSHamilton Thorne, Inc.·Product code MRX·2012-04-24
K120086 — CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CMCardiosolutions·Product code DRA·2012-04-24

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