FDA 510(k) clearances — page 407

176,542 clearances on record, most recent first.

Clearances — page 407

40,601–40,700 of 176,542

K130719 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETERInfraredx, Inc.·Product code OGZ·2013-10-17
K130942 — LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFFLegacy Medical, Inc.·Product code DXQ·2013-10-17
K130958 — TRUE SPINAL FIXATION SYSTEMInnovative Surgical Designs·Product code MNI·2013-10-17
K131013 — FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEMNova Biomedical Corporation·Product code NBW·2013-10-17
K131167 — UNIVATIONAesculap Implant Systems, LLC·Product code HRY·2013-10-17
K131459 — AAP K-WIRE, STEINMANN PIN, CERCLAGE WIREAap Implantate AG·Product code JDW·2013-10-17
K131775 — UNIVERSAL NEURO 3 SYSTEMStryker·Product code GWO·2013-10-17
K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN·Product code MHX·2013-10-17
K131994 — SOMNOLYZER 24X7Respironics, Inc.·Product code MNR·2013-10-17
K132127 — TRANSCEND AUTOSomnetics International, Inc.·Product code BZD·2013-10-17
K132251 — APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated·Product code LSL·2013-10-17
K132272 — GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATIONGlooko, Inc.·Product code NBW·2013-10-17
K132430 — STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETERBoston Scientific Corp·Product code LIT·2013-10-17
K132438 — IMAGENET 5 PC SOFTWARE SYSTEMTopcon Medical Systems, Inc.·Product code NFJ·2013-10-17
K132468 — MRSA/SA ELITE MGB, ELITE MGB SOFTWAREElitechgroup Epoch Biosciences·Product code NQX·2013-10-17
K132612 — HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCEEthicon Endo-Surgery, LLC·Product code LFL·2013-10-17
K132636 — DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEMSmith & Nephew, Inc.·Product code LLZ·2013-10-17
K132942 — SITE-RITE VISION II ULTRASOUND SYSTEMC.R. Bard, Inc.·Product code IYN·2013-10-17
K122949 — MEDLINE SUCTION COAGULATORMedline Industries, Inc.·Product code GEI·2013-10-16
K130254 — PROW FUSIONNlt Spine, Ltd.·Product code MAX·2013-10-16
K130294 — BRAEMAR CARDIOKEY HOLTER RECORDERBraemar Manufacturing, LLC·Product code MWJ·2013-10-16
K130644 — PEDIATRIC FOLDING WHEELCHAIRColumbia Medical Mfg, LLC·Product code LBE·2013-10-16
K130686 — NASAL COMFORT FREEDOMLakeview Sleep Center·Product code BZD·2013-10-16
K131022 — OVATION 10/12 HIP STEMOrtho Development Corp.·Product code LPH·2013-10-16
K131047 — FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technololgy Co., Ltd.·Product code DQA·2013-10-16
K131231 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISTornier S.A.S.·Product code PHX·2013-10-16
K131405 — IFUSE IMPLANT SYSTEMSI-BONE, Inc.·Product code OUR·2013-10-16
K131640 — SMOOTH OR THREADED METALLIC BONE FASTENERBiomedical Ent., Inc.·Product code HTY·2013-10-16
K132160 — VANTAGE TITAN 3TToshibamedical Systems Corporation·Product code LNH·2013-10-16
K132236 — .DECIMAL PROTON APERTURE.Decimal, Inc.·Product code IXI·2013-10-16
K132461 — A.I.M. SUTURE ANCHORAnchor Innovation Medical, Inc.·Product code MBI·2013-10-16
K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATORSiemens Healthcare Diagnostics, Inc.·Product code CJW·2013-10-16
K130231 — NON-CONTACT INFRARED THERMOMETERJinxinbao Electronic Co.,Ltd·Product code FLL·2013-10-15
K131234 — LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)Broncus Medical, Inc.·Product code EOQ·2013-10-15
K131991 — ENDOCHOICE HOT BIOPSY FORCEPSEndochoice, Inc.·Product code KGE·2013-10-15
K131993 — MULTICHEM UTechno-Path Manufacturing , Ltd.·Product code JJY·2013-10-15
K130123 — BASIC AND DOMINANT FLEX SUCTION PUMPSMedela AG·Product code BTA·2013-10-11
K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR)Inovise Medical, Inc.·Product code MLO·2013-10-11
K130858 — REVERSE MEDICAL MICROCATHETERReverse Medical Corporation·Product code DQY·2013-10-11
K130881 — ACUSON S2000 AND S3000Siemens Medical Solutions USA, Inc.·Product code IYN·2013-10-11
K131023 — THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC·Product code NFB·2013-10-11
K131337 — BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLAOrtho Development Corp.·Product code JWH·2013-10-11
K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.·Product code LFR·2013-10-11
K131437 — MODIFIED CONCENTRIC MICROCATHETERConcentric Medical, Inc.·Product code DQO·2013-10-11
K131502 — SEATTLE - PAPSeattle Childrens Hospital·Product code BZD·2013-10-11
K131534 — KATANA ZIRCONIAKuraray Noritake Dental, Inc.·Product code EIH·2013-10-11
K131677 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.·Product code HSB·2013-10-11
K131807 — HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems, Inc.·Product code IYE·2013-10-11
K131908 — 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·2013-10-11
K132145 — MTM(R) CLEAR ALIGNERDentsply International, Inc.·Product code NXC·2013-10-11
K132161 — OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTSExactech, Inc.·Product code JWH·2013-10-11
K132235 — IMDX C.DIFFICILE FOR ABBOTT M2000Intelligent Medical Devices, Inc.·Product code OZN·2013-10-11
K132405 — PPA/BT-RB STETHOSCOPERnk Products, Inc.·Product code DQD·2013-10-11
K132560 — PCP-USB STETHOSCOPERnk Products, Inc.·Product code DQD·2013-10-11
K132619 — CLASSIC INTERMITTENT CATHETERFlexicare Medical, Ltd.·Product code EZD·2013-10-11
K132885 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETCook Incorporated·Product code LJS·2013-10-11
K130728 — POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HASmith & Nephew, Inc.·Product code LZO·2013-10-10
K131178 — IDYS LIF CAGESClariance·Product code MAX·2013-10-10
K131365 — T2 TIBIAL NAILING SYSTEMStryker Trauma AG·Product code HSB·2013-10-10
K131422 — PEERSCOPE SYSTEMEndochoice, Inc.·Product code FDS·2013-10-10
K131636 — POLARUS CONNECTAcumed, LLC·Product code LXT·2013-10-10
K131662 — IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIALSiemens Healthcare Diagnostics, Inc.·Product code JJX·2013-10-10
K131684 — BIOLOX(R) DELTA CERAMIC HEADSBiomet, Inc.·Product code LZO·2013-10-10
K131739 — NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.·Product code FKP·2013-10-10
K131779 — VITEK 2 AST-ST TIGECYCLINEbioMerieux, Inc.·Product code LON·2013-10-10
K131797 — 3B LASER NEEDLELivetec GmbH·Product code ILY·2013-10-10
K132139 — DELTEX MEDICAL CARDIOQ-EDM+Deltex Medical Limited·Product code DPW·2013-10-10
K132303 — IMPLANET SPINE SYSTEMImplanet, S.A.·Product code OSH·2013-10-10
K132412 — INERTIA MIS PEDICLE SCREW SYSTEMNexxt Spine, LLC·Product code MNI·2013-10-10
K132482 — BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical·Product code HCG·2013-10-10
K123205 — ESOPHAGEAL TTS STENTTaewoong Medical Co., Ltd.·Product code ESW·2013-10-09
K130379 — ROLLINS 7 OXYGEN MASKRollins Medical Solutions, Inc.·Product code CAF·2013-10-09
K130390 — COMPREHENSIVE CONVERTIBLE GLENOIDBiomet Manufacturing, Inc.·Product code PHX·2013-10-09
K131207 — FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASERSurgical Instrument Engineering AG·Product code HQF·2013-10-09
K131546 — AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.·Product code KHS·2013-10-09
K131774 — HAMILTON-G5Hamilton Medical AG·Product code CBK·2013-10-09
K131981 — CEZANNE II INTERBODY FUSION SYSTEMAccel Spine·Product code MAX·2013-10-09
K132010 — VIDAS C DIFFICILE GDHBiomerieux S.A.·Product code MCB·2013-10-09
K132667 — SYNERGY ODMTopcon Medical Systems, Inc.·Product code NFJ·2013-10-09
K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiomet·Product code LXT·2013-10-09
K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONSPlaytex Manufacturing, Inc.·Product code HIL·2013-10-09
K130110 — MEDDUSA BIPOLAR SYSTEMElliquence, LLC·Product code GEI·2013-10-08
K130834 — R7Cefla S.C.·Product code ELC·2013-10-08
K130857 — PRONTOSAN WOUND GEL XB.Braun Medical, Inc.·Product code FRO·2013-10-08
K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTCook Biotech, Inc.·Product code GXQ·2013-10-08
K131186 — SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEMSynthes (USA) Products, LLC·Product code HRS·2013-10-08
K131353 — COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHEREBiomet Manufacturing Corp·Product code PHX·2013-10-08
K131362 — INMODE WMBODY DEVICEInmode MD , Ltd.·Product code NUV·2013-10-08
K131472 — APEX KNEE MODULAR TIBIA SYSTEMOmni Life Science, Inc.·Product code JWH·2013-10-08
K131585 — INTEL-GE CARE INNOVATIONS QUIETCAREIntel-Ge Care Innovations, LLC·Product code KMI·2013-10-08
K132142 — NERIA SOFT 90 INFUSION SETUnomedical A/S·Product code FPA·2013-10-08
K132224 — UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODESUnimed Surgical Products, Inc.·Product code GEI·2013-10-08
K132362 — WECK EFX ENDO FASCIAL CLOSURE SYSTEMTeleflexmedical, Inc.·Product code OCW·2013-10-08
K132471 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2013-10-08
K132589 — ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)Life Spine, Inc.·Product code KWQ·2013-10-08
K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSBaxter Healthcare Corp·Product code FPA·2013-10-08
K132829 — QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSMaquet Cardiopulmonary, AG·Product code DTZ·2013-10-08
K130709 — VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc.·Product code MWI·2013-10-07
K130940 — KYMCO EQ20C SCOOTERKwang Yang Motor Co., Ltd.·Product code INI·2013-10-07
K131143 — TRELLIS COLLAGEN RIBBONWrightmedicaltechnologyinc·Product code OWY·2013-10-07

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