FDA 510(k) clearances — page 400

176,542 clearances on record, most recent first.

Clearances — page 400

39,901–40,000 of 176,542

K133256 — ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMConformis, Inc.·Product code JWH·2014-01-09
K133261 — MEDOS HILITE 7000 & 7000 LT OXYGENATORMedos Medizintechnik AG·Product code DTZ·2014-01-09
K133286 — MIDLINE (TM)Centinel Spine, Inc.·Product code OVD·2014-01-09
K133321 — ALAMO CAlliance Partners, LLC·Product code ODP·2014-01-09
K133371 — RAMPART-LSpineology, Inc.·Product code MAX·2014-01-09
K133520 — HAMMERLOCK 2Biomedical Enterprises, Inc.·Product code HTY·2014-01-09
K130476 — ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGEDental Morelli·Product code OAT·2014-01-08
K130681 — ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBERBiolitec Sia·Product code GEX·2014-01-08
K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.·Product code DRC·2014-01-08
K131000 — V-PATCH SYSTEMIntelesens Limited·Product code DSI·2014-01-08
K132247 — ULTRASONIC MESH NEBULIZERFoshan Gaunying Electronics Co., Ltd.·Product code CAF·2014-01-08
K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)Nanosphere, Inc.·Product code PEN·2014-01-08
K132880 — MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLEMedical Components, Inc.·Product code FPA·2014-01-08
K133049 — 3I T3(R) EXTERNAL HEX DENTAL IMPLANTSBiomet 3i·Product code DZE·2014-01-08
K133452 — EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEMEmerge Medical·Product code HRS·2014-01-08
K133747 — ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEMEndochoice, Inc.·Product code FEQ·2014-01-08
K133750 — OCCLUDER OCCLUSION BALLOON CATHETERBoston Scientific Corporation·Product code EYB·2014-01-08
K133762 — ENDO GIA(TM) EXTRA LONG ADAPTERCovidien, LLC·Product code GDW·2014-01-08
K124033 — MEDISISS REPROCESSED ULTRASONIC INSTRUMENTSSurgical Instruments Service and Savings, Inc.·Product code NLQ·2014-01-07
K130122 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTERBeckman Coulter, Inc.·Product code CFN·2014-01-07
K131832 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShandong Binxiang Medical Products Co., Ltd.·Product code LYZ·2014-01-07
K132296 — D-RAD SMART PACKSmith & Nephew, Inc.·Product code HRS·2014-01-07
K132581 — MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGECardica, Inc.·Product code GDW·2014-01-07
K132677 — ULTRASOUND SCANNER FLEX FOCUS 1202B-K Medical Aps·Product code IYN·2014-01-07
K132735 — AXIA RADIAL HEAD SYSTEMImds (Innovative MEdical Device Systems) - Leis ME·Product code KWI·2014-01-07
K133167 — MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORDIntuitive Surgical, Inc.·Product code GEI·2014-01-07
K133413 — IDSS SLCBlack Diamond Video·Product code FTA·2014-01-07
K133736 — ENDOSCOPIC SUTURE CUTTERUnited States Endoscopy Group, Inc.·Product code OCZ·2014-01-07
K123262 — OPTIFLUX ULTRA DIALYZERFresenius Medical Care North America·Product code KDI·2014-01-06
K131276 — LATERAL SYNFIXSynthes (USA) Products, LLC·Product code OVD·2014-01-06
K131461 — LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINILed Intellectual Properties, LLC·Product code OLP·2014-01-06
K131469 — ACON ON CALL DIABETES MANAGEMENT SOFTWAREACON Laboratories, Inc.·Product code NBW·2014-01-06
K132439 — SAKURA STEAM STERILIZER ASSR +2 moreSakura Seiki Co., Ltd.·Product code FLE·2014-01-06
K132685 — ULTRASOUND SCANNER PRO FOCUS 2202B-K Medical Aps·Product code IYN·2014-01-06
K132769 — ACUMED HAND PLATING SYSTEMAcumed, LLC·Product code HRS·2014-01-06
K132830 — DISTALOCK TIBIAL IM NAIL SYSTEMDgimed Ortho, Inc.·Product code HSB·2014-01-06
K133686 — 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)Jvckenwood Corporation·Product code LLZ·2014-01-06
K133826 — INTONEMVIncontrol Medical, LLC·Product code KPI·2014-01-06
K130606 — FMWAND FERROMAGNETIC SURGICAL SYSTEMDomain Surgical, Inc.·Product code HGI·2014-01-03
K130937 — WAVE 2G, SOULHansaton Akustik GmbH·Product code KLW·2014-01-03
K130998 — SYNGO.VIA WEB VIEWERSiemens AG Medical Solutions·Product code LLZ·2014-01-03
K131272 — SIREN EPCR SUITEMedusa Medical Technologies, Inc.·Product code DXJ·2014-01-03
K131516 — PRISMAFLEX SYSTEM 7.10Gambro Renal Products, Inc.·Product code KDI·2014-01-03
K131880 — SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEMSpinefrontier, Inc.·Product code OVE·2014-01-03
K132399 — ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVELElitechgroup·Product code JFY·2014-01-03
K132733 — ORTHOHELIX SYNDESMOSIS FIXATION DEVICESOrthohelix Surgical Designs, Inc.·Product code HTN·2014-01-03
K132923 — FUSION SINGLE LINKAngelus Industria DE Productos Odontologicos SA·Product code KLE·2014-01-03
K133146 — BAUSCH + LUMB, VIS100 INJECTOR SYSTEMBausch & Lomb·Product code MSS·2014-01-03
K133224 — Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURESConmed Corporation·Product code MBI·2014-01-03
K133312 — EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLEBoston Scientific Corporation·Product code ODG·2014-01-03
K133645 — PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code MAX·2014-01-03
K133714 — TRU FLUMeridian Bioscience, Inc.·Product code PSZ·2014-01-03
K130670 — HYDROFERA BLUE PU BACTERIOSTATIC DRESSINGHydrofera, LLC·Product code FRO·2014-01-02
K130901 — SOMATOM DEFINITION AS OPENSiemens Medical Systems, Inc.·Product code JAK·2014-01-02
K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPEKARL STORZ Endoscopy-America, Inc.·Product code FBO·2014-01-02
K132661 — LIGHTSCALPELLightscalpel, LLC·Product code GEX·2014-01-02
K132969 — SPEC MODEL M15Source Production & Equipment Co., Inc.·Product code KXK·2014-01-02
K133393 — GELPOINT PATH TRANSANAL ACCESS PLATFORMApplied Medical Resources Corp.·Product code FER·2014-01-02
K133512 — LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)Siemens Healthcare Diagnostics·Product code CDD·2014-01-02
K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMThe Anspach Effort, Inc.·Product code ERL·2013-12-31
K132520 — NASAL EASE ALLERGY BLOCKERHi-Tech Pharmacal, Inc.·Product code NUP·2013-12-31
K132629 — REPROCESSED DILATING TIP TROCARSStryker Sustainability Solutions·Product code NLM·2013-12-31
K133026 — UNBALLOON NON-OCCLUSION MODELING CATHETERLeMaitre Vascular, Inc.·Product code DQY·2013-12-31
K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL NAdvanced Orthopaedic Solutions, Inc.·Product code HSB·2013-12-31
K133806 — M1 CAPNOGRAPHY MASKMonitor Mask, Inc.·Product code CCK·2013-12-31
K132308 — CLIQ DV-300 ASPIRATORDing Hwa Co., Ltd.·Product code JCX·2013-12-30
K132559 — MONUMENT SPACERSGlobus Medical, Inc.·Product code OVD·2013-12-30
K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker Communications·Product code FSY·2013-12-30
K132867 — SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MMCayenne Medical, Inc.·Product code MBI·2013-12-30
K132875 — COMPRESSYN STAPLEDallen Medical, Inc.·Product code JDR·2013-12-30
K133490 — G-SCAN BRIOEsaote, S.p.A.·Product code LNH·2013-12-30
K130895 — REUNION RSA SHOULDER SYSTEMHowmedica Osteonics Corp.·Product code PHX·2013-12-27
K131050 — NXSTAGE 1.6M2 DIALYZERNxstage Medical, Inc.·Product code KDI·2013-12-27
K131259 — LASER-STIMShenzhen Dongdixin Technology Co., Ltd.·Product code ILY·2013-12-27
K131789 — CEREBRALOGIK- AEEGMennen Medical , Ltd.·Product code OMA·2013-12-27
K132007 — STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REUStericycle, Inc.·Product code MMK·2013-12-27
K132481 — EASY-LOAD LENS DELIVERY SYSTEMBausch & Lomb·Product code MSS·2013-12-27
K132674 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)Becton, Dickinson and Company·Product code LON·2013-12-27
K133505 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMSamsung Medison Co., Ltd.·Product code IYN·2013-12-27
K130570 — NEUROVISION MEDICAL MOTION SENSORNeurovision Medical Products, Inc.·Product code BZQ·2013-12-26
K132095 — OLEA SPHEREOlea Medical·Product code LLZ·2013-12-26
K133111 — KINGTECH DIGITAL THERMOMETERKingtech Enterprise, Ltd.·Product code FLL·2013-12-26
K133113 — KINGTECH FOREHEAD THERMOMETERKingtech Enterprise, Ltd.·Product code FLL·2013-12-26
K133283 — CANDELA GENTLEMAX FAMILY OF LASER SYSTEMSCandela Corp.·Product code GEX·2013-12-26
K133422 — 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGENeocoil, LLC·Product code MOS·2013-12-26
K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSImmunodiagnostic Systems , Ltd.·Product code CIB·2013-12-24
K130325 — ARM AUTOMATIC BLOOD PRESSURE MONITORShenzhen Pump Medical System Co., Ltd.·Product code DXN·2013-12-24
K130519 — PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPSPhilips Lighting Company·Product code FTC·2013-12-24
K130572 — INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMImplant Direct Sybron Manufacturing, LLC·Product code DZE·2013-12-24
K130975 — SWABCAP AND SWABFLUSHExcelsior Medical Corp.·Product code QBP·2013-12-24
K130977 — SIGNIFY BIOACTIVEGlobus Medical, Inc.·Product code MQV·2013-12-24
K131164 — ACUSONSiemens Medical Solutions USA, Inc.·Product code IYN·2013-12-24
K131169 — MOZEC - RX PTCA BALLOON DILATATION CATHETERMeril Life Sciences Private Limited·Product code LOX·2013-12-24
K131447 — INTUITION - TDA, TVA, PARAMETRIC MAPPINGTerarecon,Inc.·Product code LLZ·2013-12-24
K131521 — VELOX ANTERIOR CERVICAL PLATE SYSTEMSpinecraft, LLC·Product code KWQ·2013-12-24
K131724 — PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICEPioneer Surgical Technology, Inc.·Product code MQP·2013-12-24
K132511 — FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEMAbbott Diabetes Care, Inc.·Product code NBW·2013-12-24
K132601 — COROENT STERILE IMPLANTS SYSTEMNu Vasive, Incorporated·Product code MAX·2013-12-24
K132787 — LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATEAap Implantate AG·Product code HRS·2013-12-24
K133431 — VENUE 50GE Healthcare·Product code IYN·2013-12-24

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