FDA 510(k) clearances — page 431

175,770 clearances on record, most recent first.

Clearances — page 431

43,001–43,100 of 175,770

K113678 — INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEMMedela AG·OMP·2012-10-01
K120116 — SERF ABLATION SYSTEM SERF ABLATION NEEDLEThermedical·GEI·2012-10-01
K120460 — SMARTLUXMedmix Co., Ltd.·GEX·2012-10-01
K120891 — TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEMUlrich GmbH & Co. KG·NKB·2012-10-01
K120998 — SOLSTICE CROSS CONNECTORLife Spine·KWP·2012-10-01
K121425 — ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEMWrightmedicaltechnologyinc·HRS·2012-10-01
K121458 — SPEEDICATH COMPACT SET (12/18 FR)Coloplast A/S·GBM·2012-10-01
K121672 — AFT PROXIMAL HUMERUS FRACTURE PLATEShoulder Options, Inc.·HRS·2012-10-01
K121684 — NOVATION LPI PRIME FEMORAL STEMExactech, Inc.·LPH·2012-10-01
K122226 — REVERE STABILIZATION SYSTEMGlobus Medical, Inc.·NKB·2012-10-01
K122308 — AXSOS DISTAL LATERAL FEMUR TS LONG PLATESHowmedica Osteonics Corp., Dba Stryker Orthopaedics·HRS·2012-10-01
K122511 — ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATHEthicon Endo-Surgery, LLC·GCJ·2012-10-01
K112628 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SETNipro Medical Corporation·FJK·2012-09-28
K113852 — BAUSCH & LOMB IOL INJECTORBausch & Lomb, Inc.·MSS·2012-09-28
K120289 — PEERSCOPE SYSTEMPeermedical·FDF·2012-09-28
K120982 — DIGITAL EYE-FUNDUS CAMERAMedimaging Integrated Solutions, Inc. (Miis)·HKI·2012-09-28
K121286 — EPIC 10Biolase Technology, Inc.·GEX·2012-09-28
K121462 — EZ-BLOCKEREz-Blocker B.V.·CBI·2012-09-28
K121761 — SOMNOGUARD SP SOFTTomed Dr. Toussaint GmbH·LRK·2012-09-28
K121806 — BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARECovidien·DQA·2012-09-28
K121915 — BRIGHT RESTORATIVE MATERIALSDmp, Ltd.·EBF·2012-09-28
K122072 — WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STEBoston Scientific Corporation·FGE·2012-09-28
K122232 — GMK NARROWMedacta International·JWH·2012-09-28
K122263 — 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USESymmetry Medical·ODY·2012-09-28
K122270 — OVERTUBE ENDOSCOPIC ACCESS SYSTEMApollo Endosurgery, Inc.·FED·2012-09-28
K122433 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·NKB·2012-09-28
K122451 — EXACTRAC VEROBrainlab AG·IYE·2012-09-28
K122641 — MPACT EXTENSIONMedacta International·LZO·2012-09-28
K122825 — ACUSONSiemens Medical Solutions USA, Inc.·IYN·2012-09-28
K113843 — FREEDOM ND: YAG LASER SYSTEMLutronic Corporation·PDZ·2012-09-27
K120306 — RAPICIDE OPA-28Minntech Corp.·MED·2012-09-27
K120635 — EASYONE PRO RESPIRATORY TESTING DEVICENdd Medizitechnik AG·BTY·2012-09-27
K121504 — SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETSTogo Medikit Co., Ltd.·DYB·2012-09-27
K121713 — PMT BONE SCREWSProvidence Medical Technology, Inc.·HWC·2012-09-27
K121971 — WITHINGS, SMART BODY SCALEZhongshan Transtek Electronics Co., Ltd.·MNW·2012-09-27
K122033 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·JWH·2012-09-27
K122067 — TYPE 1077 ACCUSCREENGn Otometrics·GWJ·2012-09-27
K122096 — KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEMKARL STORZ Endoscopy-America, Inc.·HAW·2012-09-27
K122266 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Shandong Junfeng Industries Co., Ltd.·LYZ·2012-09-27
K111391 — STERRAD (R) 100NX DUO CYCLE TEST PACKAdvanced Sterilization Products·FRC·2012-09-26
K113483 — ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATIONPhilips Healthcare (Cleveland)·JAK·2012-09-26
K120087 — EXSPIRONRespiratory Motion, Inc.·BZK·2012-09-26
K120136 — EMBRYOGENOrigio A/S·MQL·2012-09-26
K121144 — ELECTRONIC STETHOSCOPESharp Corporation·DQD·2012-09-26
K121567 — ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMAccel Spine·MAX·2012-09-26
K122022 — ATHEROEDGEAtheropoint, LLC·LLZ·2012-09-26
K122341 — PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37Hitachi Aloka Medical, Ltd.·IYN·2012-09-26
K122507 — DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATIONCardinal Health200, LLC·FRG·2012-09-26
K122611 — COOLRAIL LINEAR PEN MODEL MCRIAtriCure, Inc.·OCL·2012-09-26
K122623 — SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFTAdvanced Orthopaedic Solutions, Inc.·HRS·2012-09-26
K113120 — CHF-Y0005Olympus Medical Systems Corp.·FBN·2012-09-25
K120907 — ZOLL R SERIESZoll Medical Corporation, World Wide Headquarters·MKJ·2012-09-25
K121219 — ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETERMedtronic, Inc.·DQY·2012-09-25
K121305 — STERLING MEDICAL IMPULSE 3 STIMULATORArmstrong Industries, Inc. Dha Mediquip Int. Dha S·GZJ·2012-09-25
K121580 — SURELASE CO2 LASER SYSTEMClinicon Corp.·GEX·2012-09-25
K121665 — BENCOX FORET & BENCOX DELTACorentec Co., Ltd.·LZO·2012-09-25
K121755 — CUSTOM CRANIOFACIAL IMPLANT (CCI)Kelyniam Global, Inc.·GXN·2012-09-25
K121880 — DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUIDDanville Materials, Inc.·EBF·2012-09-25
K122374 — ARTHREX SUTURE (UHMWPE)Arthrex, Inc.·GAT·2012-09-25
K122428 — FAXITRON SPECIEN RADIOGRAPHY SYSTEMFaxitron Bioptics, LLC·MWP·2012-09-25
K122638 — TOSHIBA 3T 32CH HEAD SPEEDER COIL,Quality Electrodynamics·MOS·2012-09-25
K112449 — QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TESTTianjin New Bay Bioresearch Co., Ltd.·LCX·2012-09-24
K113836 — BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba·FRO·2012-09-24
K120938 — THE PL-1064 LASER SYSTEMSheaumann Laser, Inc.·PDZ·2012-09-24
K121021 — INOMAX DS (DELIVERY SYSTEM)Ino Therapeutics·MRN·2012-09-24
K121656 — GEMINI LITHOTRIPTERDornier Medtech America, Inc.·LNS·2012-09-24
K121707 — LEW MDI O-BALL COLLARED IMPLANT,Park Dental Research Corp.·DZE·2012-09-24
K122259 — BLOOD PRESSURE MONITOR WITH STETHOSCOPEHangzhou Reli-On Co., Ltd.·DXQ·2012-09-24
K111142 — ECHOSOFT(TM)Echometrix, LLC·LLZ·2012-09-21
K112958 — HUMID-VENT HEPATeleflex Medical·CAH·2012-09-21
K120943 — SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDERArthroCare Corporation·MBI·2012-09-21
K121005 — ADIPREP ADIPOSE TRANSFER SYSTEMHarvest Technologies, Corp.·MUU·2012-09-21
K121150 — ALMA LASERS FAMILY OF PIXEL RF TIPSAlma Lasers, Inc.·GEI·2012-09-21
K121260 — TROOPER OXYGEN CONCENTRATORVbox, Inc.·CAW·2012-09-21
K121558 — DIAZYME HSCRP POC TEST KITDiazyme Laboratories·DCK·2012-09-21
K121568 — DALI SPINAL FIXATION SYSTEMAccel Spine·NKB·2012-09-21
K121589 — BIOMET MICROFIXATION FACIAL PLATING SYSTEMBiomet Microfixation·JEY·2012-09-21
K121674 — ASPIRE HD PLUS, ASPIRE HD-SFujifilm Medical System U.S.A., Inc.·MUE·2012-09-21
K121773 — NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODEBiomerics·GXI·2012-09-21
K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CMMedical Components, Inc.·MSD·2012-09-21
K122026 — PRISM ACQUIRE PRISM PROCESS PRISM VIEWPrism Clinical Imaging, Inc.·LNH·2012-09-21
K122089 — OSTIAL PRO STENT POSITIONING SYSTEMMerit Medical Systems, Inc.·DQX·2012-09-21
K122109 — AQUILION ONE VISION, V4.90Toshiba America Medical Systems, In.C·JAK·2012-09-21
K122327 — VOLUSON E6/E8/E8EXPERT/E10GE Healthcare·IYN·2012-09-21
K113282 — CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIORiemser Arzeimittel AG·LYC·2012-09-20
K113720 — RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3Randox Laboratories, Ltd.·JJY·2012-09-20
K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORSInova Diagnostics, Inc.·MST·2012-09-20
K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)Inovise Medical, Inc.·MLO·2012-09-20
K120501 — CHAMP CHAMP TRANSITConvaid Products, Inc.·IOR·2012-09-20
K120867 — VIPER AND EXPEDIUM NAVIGATED INSTRUMENTSMedos International SARL·OLO·2012-09-20
K121056 — METS MODULAR PROXIMAL FEMURStanmore Implants Worldwide , Ltd.·JDI·2012-09-20
K121262 — MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READYMedefil, Inc.·NGT·2012-09-20
K121590 — VESTIBULAR ANALYSIS APPARATUSCapacity Sports, LLC·LXV·2012-09-20
K121676 — 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTGe Medical Systems, LLC·LNH·2012-09-20
K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.·FCW·2012-09-20
K121729 — E-CUBE 7Alpinion Medical Systems Co., Ltd.·IYN·2012-09-20
K121850 — Typhoon(TM) Facet Screw Fixation SystemChoicespine, LP·MRW·2012-09-20
K121926 — BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DMNorthstar Healthcare Holdings·LZC·2012-09-20
K122021 — STERISPINE LC CAGESafe Orthopaedics·MAX·2012-09-20
K122373 — NEOMED ORAL/ENTERAL SYRINGENeomed, Inc.·FMF·2012-09-20

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