FDA 510(k) clearances — page 443

176,542 clearances on record, most recent first.

Clearances — page 443

44,201–44,300 of 176,542

K112534 — LIFECELL TISSUE EXPANDERLifecell Corp.·Product code LCJ·2012-08-10
K113210 — ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KITIsoaid, LLC·Product code KXK·2012-08-10
K113338 — MEDICAL AIR COMPRESSOROricare, Inc.·Product code BTI·2012-08-10
K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code CDN·2012-08-10
K113607 — BIOPSY DIGIT S BIOPSY SLGiotto USA, LLC·Product code IZH·2012-08-10
K113685 — POWDER FREE LATEX EXAMINATION GLOVESKhai Hoan Joint Stock Company·Product code LYY·2012-08-10
K120278 — WIRELESS IMAGE TRANSMITTER UNITOlympus Medical Systems Corp.·Product code GCJ·2012-08-10
K120554 — ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITORSejoy Electronics & Instruments Co., Ltd.·Product code DXN·2012-08-10
K120715 — ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORTZimmer GmbH·Product code HSB·2012-08-10
K120847 — ET/SS IMPLANT SYSTEMOsstem Implant Co., Ltd.·Product code DZE·2012-08-10
K121197 — BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECTPreventice, Inc.·Product code DSI·2012-08-10
K121320 — C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGEMedyssey Co, Ltd.·Product code ODP·2012-08-10
K121368 — NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)Matang Mfg. Sdn. Bhd.·Product code LZA·2012-08-10
K121390 — LUBE JELLY SURINGENurse Assist, Inc.·Product code KMJ·2012-08-10
K121429 — AIMAGO EASYLDI MICROCIRCULATION CAMERAAimago SA·Product code DPT·2012-08-10
K121513 — MULTIX FUSIONSiemens Medical Solution·Product code KPR·2012-08-10
K121632 — COMFORT EZSimple Diagnostics, Inc.·Product code FMI·2012-08-10
K121785 — SCEPTER C OCCLUSION BALLOON CATHETERMicroVention, Inc.·Product code MJN·2012-08-10
K121997 — IMRIS ONCOLOGY PACKAGEImris, Inc.·Product code LNH·2012-08-10
K113692 — XENXXenolith Medical·Product code OCY·2012-08-09
K120553 — ESPINNlt Spine, Ltd.·Product code HRX·2012-08-09
K120714 — PICASSO MIS SPINAL FIXATION SYSTEMAccel Spine·Product code NKB·2012-08-09
K120781 — CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTHFuji Systems Corp.·Product code DQY·2012-08-09
K121136 — RENOIR POSTERIOR CERVIAL FIXATION SYSTEMAccel Spine·Product code KWP·2012-08-09
K121142 — CRAWFORD BIOCANALICULUS INTUBATIONFci Sas (France Chirurgie Instrumentation)·Product code OKS·2012-08-09
K121221 — PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyinc·Product code LZO·2012-08-09
K121524 — INSIGNIAOrmco Corp.·Product code DYW·2012-08-09
K112162 — CONICAL CONNECTION IMPLANTSMis Implants Technologies , Ltd.·Product code DZE·2012-08-08
K112787 — KERATORKj Meditech Co., Ltd.·Product code NHA·2012-08-08
K113507 — KENT CAMERAKent Imaging, Inc.·Product code MUD·2012-08-08
K113776 — FLASHPAKSymmetry Medical·Product code FRG·2012-08-08
K113820 — NEUTROPHASE ANTIMICROBIAL WOUND CLEANSERNovabay Pharmaceuticals·Product code FRO·2012-08-08
K120585 — CONVEY GUIDING CATHETERPendracare International, B.V.·Product code DQY·2012-08-08
K121102 — OSTEOSYMBIONICS PEEK CRANIAL IMPLANTOsteosymbionics, LLC·Product code GXN·2012-08-08
K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTHAptus Endosystems, Inc.·Product code OTD·2012-08-08
K121172 — REFORM PEDICLE SCREW SYSTEMSpinal USA·Product code MNI·2012-08-08
K121839 — UNBALLOON NON-OCCLUSIVE MODELING CATHETERLeMaitre Vascular, Inc.·Product code DQY·2012-08-08
K111953 — NAUTILUS SPINAL SYSTEMLife Spine·Product code NKB·2012-08-07
K113783 — VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAEbioMerieux, Inc.·Product code LON·2012-08-07
K113795 — SUCTION LIPOLASTY ACCESSORIESNorman M. Black Iii·Product code QPB·2012-08-07
K120994 — BD BACTEC Plus PRIME Aerobic/F Culture VialsBecton, Dickinson and Company·Product code MDB·2012-08-07
K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZimmer Medizinsystems GmbH·Product code IMG·2012-08-07
K121393 — SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.·Product code MBH·2012-08-07
K122141 — IDS-ISYS IGF-I CALIBRATION VERIFIERSImmunodiagnostic Systems , Ltd.·Product code JJX·2012-08-07
K112532 — ET II BIO-SA FIXTURE SYSTEMHiossen, Inc.·Product code DZE·2012-08-06
K113437 — ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code LCP·2012-08-06
K120536 — HEART SYNC PEDIATRIC PHYSIO AED PADHeart Sync, Inc.·Product code MKJ·2012-08-06
K121158 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERSSterilmed, Inc.·Product code NLH·2012-08-06
K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.·Product code EJR·2012-08-06
K122006 — G-SCAN BRIOEsaote, S.p.A.·Product code LNH·2012-08-06
K112692 — IDENTIFYHumediq GmbH·Product code IYE·2012-08-03
K113077 — BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code NBW·2012-08-03
K113536 — MASTERKA 40 MASTERKA 35 MASTERKA 30Fci Sas (France Chirurgie Instrumentation)·Product code OKS·2012-08-03
K113673 — MYSAFETY SYRINGEMedicalchain Internartional Corporation·Product code FMF·2012-08-03
K120423 — BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650Bionime Corporation·Product code NBW·2012-08-03
K120451 — 8MP COLOR LCD MONITOR, REDIFORCE RX840Eizo Nanao Corporation·Product code LLZ·2012-08-03
K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CARichard Wolf Medical Instruments Corp.·Product code OTJ·2012-08-03
K120961 — TREVO RETRIEVERConcentric Medical, Inc.·Product code NRY·2012-08-03
K121048 — ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVEREDBoston Scientific Corp·Product code JCT·2012-08-03
K121192 — NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)Tekmedic (M) Sdn Bhd·Product code LZA·2012-08-03
K121289 — LTM-LABAROSCOPIC SURGICAL MESHLifecell Corp.·Product code OXK·2012-08-03
K121337 — UROPLASTY RIGID ENDOSCPIC NEEDLESUroplasty, Inc.·Product code FBK·2012-08-03
K121526 — POWER-FREE NITRILE PATIENT EXAMINATION GLOVESShandong Junchi Medical Products Co., Ltd.·Product code LZA·2012-08-03
K121789 — SHANGRINGWuhu Snna Medical Treatment Appliance Technology C·Product code HFX·2012-08-03
K121990 — PICC CONVENIENCE KITNavilyst Medical, Inc.·Product code LJS·2012-08-03
K121996 — BE PLUS LTM AMPLIFIER GWI AMPLIFIEREb Neuro S.P.A.·Product code GWL·2012-08-03
K122118 — HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEMCodman & Shurtleff, Inc.·Product code JXG·2012-08-03
K111534 — ABACUS 3CPDiatron U.S., Inc.·Product code GKZ·2012-08-02
K112620 — DISITAL BLOOD PRESSURE MONITORNihon Seimitsu Sokki Co., Ltd.·Product code DXN·2012-08-02
K112864 — SOFTSEAL-CChitogen, Inc.·Product code QSY·2012-08-02
K120430 — MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3PMicrolife Intellectual Property GmbH·Product code DXN·2012-08-02
K120734 — MICROSOFT AMALGA UIS IMAGE PROCESSING MODULEMicrosoft Corp.·Product code LLZ·2012-08-02
K120917 — HEADWAY DUO MICROCATHETERMicroVention, Inc.·Product code DQO·2012-08-02
K121157 — POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Shijazhuang Jiuyuan Plastic Co., Ltd.·Product code LYZ·2012-08-02
K121184 — SENSUSNeurometrix, Inc.·Product code GZJ·2012-08-02
K121267 — BT-200V VASCULAR DOPPLERBistos Co., Ltd.·Product code HGM·2012-08-02
K121410 — DRAGON LWSedecal., Sa.·Product code IZL·2012-08-02
K121525 — PERIFUSE CATHETERSmiths Medical Asd, Inc.·Product code CAZ·2012-08-02
K121867 — SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMSChison Medical Imaging Co., Ltd.·Product code IYN·2012-08-02
K121940 — LANX SPINAL FIXATION SYSTEMLanx, Inc.·Product code NKB·2012-08-02
K122073 — ELI 280 ELECTROCARDIOGRAPHMortara Instrument, Inc.·Product code DPS·2012-08-02
K122121 — PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULEPulsion Medical Systems SE·Product code DXG·2012-08-02
K113289 — ORION MICRO CATHETERMicro Therapeutics, Inc.·Product code KRA·2012-08-01
K113560 — CELOX GAUZE PROMedtrade Products , Ltd.·Product code QSY·2012-08-01
K121014 — SOLAR GIMedical Measurement Systems B.V.·Product code FFX·2012-08-01
K121938 — MEDILAS H RFID LASER FIBERDornier Medtech America, Inc.·Product code GEX·2012-08-01
K121987 — WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TESTGuangzhou Wondfo Biotech Co., Ltd.·Product code DKZ·2012-08-01
K112545 — QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBMInova Diagnostics, Inc.·Product code MOB·2012-07-31
K112818 — VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.·Product code DAP·2012-07-31
K113118 — STENTUBE LACRIMAL INTUBATION SETQuest Medical, Inc.·Product code OKS·2012-07-31
K113849 — HQS INTRODUCERAlseal·Product code DYB·2012-07-31
K120283 — DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENTNovocol, Inc.·Product code EMA·2012-07-31
K120414 — OSSEOSPEED PLUSAstra Tech AB·Product code DZE·2012-07-31
K120426 — VICTUS LASER PLATFORMTechnolas Perfect Vision GmbH·Product code OOE·2012-07-31
K120838 — SYNTHES MATRIX SYSTEMSynthes Spine·Product code NKB·2012-07-31
K121053 — DIAZYME HOMOCYSTEINE POC TEST KITDiazyme Laboratories·Product code LPS·2012-07-31
K121578 — ATOM 1 (MODEL: BRC 2200)Bioelectric Research Corporation·Product code GZJ·2012-07-31
K113199 — KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KITKevo Medical Supplies·Product code OMP·2012-07-30
K120467 — SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEMSpinal Elements, Inc.·Product code NKB·2012-07-30
K120511 — AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEMLeto Enterprise , Ltd.·Product code NFO·2012-07-30

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