FDA 510(k) clearances — page 439

176,542 clearances on record, most recent first.

Clearances — page 439

43,801–43,900 of 176,542

K122825 — ACUSONSiemens Medical Solutions USA, Inc.·Product code IYN·2012-09-28
K113843 — FREEDOM ND: YAG LASER SYSTEMLutronic Corporation·Product code PDZ·2012-09-27
K120306 — RAPICIDE OPA-28Minntech Corp.·Product code MED·2012-09-27
K120635 — EASYONE PRO RESPIRATORY TESTING DEVICENdd Medizitechnik AG·Product code BTY·2012-09-27
K121504 — SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETSTogo Medikit Co., Ltd.·Product code DYB·2012-09-27
K121713 — PMT BONE SCREWSProvidence Medical Technology, Inc.·Product code HWC·2012-09-27
K121971 — WITHINGS, SMART BODY SCALEZhongshan Transtek Electronics Co., Ltd.·Product code MNW·2012-09-27
K122033 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2012-09-27
K122067 — TYPE 1077 ACCUSCREENGn Otometrics·Product code GWJ·2012-09-27
K122096 — KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEMKARL STORZ Endoscopy-America, Inc.·Product code HAW·2012-09-27
K122266 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)Shandong Junfeng Industries Co., Ltd.·Product code LYZ·2012-09-27
K111391 — STERRAD (R) 100NX DUO CYCLE TEST PACKAdvanced Sterilization Products·Product code FRC·2012-09-26
K113483 — ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATIONPhilips Healthcare (Cleveland)·Product code JAK·2012-09-26
K120087 — EXSPIRONRespiratory Motion, Inc.·Product code BZK·2012-09-26
K120136 — EMBRYOGENOrigio A/S·Product code MQL·2012-09-26
K121144 — ELECTRONIC STETHOSCOPESharp Corporation·Product code DQD·2012-09-26
K121567 — ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMAccel Spine·Product code MAX·2012-09-26
K122022 — ATHEROEDGEAtheropoint, LLC·Product code LLZ·2012-09-26
K122341 — PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37Hitachi Aloka Medical, Ltd.·Product code IYN·2012-09-26
K122507 — DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATIONCardinal Health200, LLC·Product code FRG·2012-09-26
K122611 — COOLRAIL LINEAR PEN MODEL MCRIAtriCure, Inc.·Product code 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.·Product code HRS·2012-09-26
K113120 — CHF-Y0005Olympus Medical Systems Corp.·Product code FBN·2012-09-25
K120907 — ZOLL R SERIESZoll Medical Corporation, World Wide Headquarters·Product code MKJ·2012-09-25
K121219 — ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETERMedtronic, Inc.·Product code DQY·2012-09-25
K121305 — STERLING MEDICAL IMPULSE 3 STIMULATORArmstrong Industries, Inc. Dha Mediquip Int. Dha S·Product code GZJ·2012-09-25
K121580 — SURELASE CO2 LASER SYSTEMClinicon Corp.·Product code GEX·2012-09-25
K121665 — BENCOX FORET & BENCOX DELTACorentec Co., Ltd.·Product code LZO·2012-09-25
K121755 — CUSTOM CRANIOFACIAL IMPLANT (CCI)Kelyniam Global, Inc.·Product code GXN·2012-09-25
K121880 — DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUIDDanville Materials, Inc.·Product code EBF·2012-09-25
K122374 — ARTHREX SUTURE (UHMWPE)Arthrex, Inc.·Product code GAT·2012-09-25
K122428 — FAXITRON SPECIEN RADIOGRAPHY SYSTEMFaxitron Bioptics, LLC·Product code MWP·2012-09-25
K122638 — TOSHIBA 3T 32CH HEAD SPEEDER COIL,Quality Electrodynamics·Product code MOS·2012-09-25
K112449 — QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TESTTianjin New Bay Bioresearch Co., Ltd.·Product code LCX·2012-09-24
K113836 — BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)Avery Dennison Belgie Bvba·Product code FRO·2012-09-24
K120938 — THE PL-1064 LASER SYSTEMSheaumann Laser, Inc.·Product code PDZ·2012-09-24
K121021 — INOMAX DS (DELIVERY SYSTEM)Ino Therapeutics·Product code MRN·2012-09-24
K121656 — GEMINI LITHOTRIPTERDornier Medtech America, Inc.·Product code LNS·2012-09-24
K121707 — LEW MDI O-BALL COLLARED IMPLANT,Park Dental Research Corp.·Product code DZE·2012-09-24
K122259 — BLOOD PRESSURE MONITOR WITH STETHOSCOPEHangzhou Reli-On Co., Ltd.·Product code DXQ·2012-09-24
K111142 — ECHOSOFT(TM)Echometrix, LLC·Product code LLZ·2012-09-21
K112958 — HUMID-VENT HEPATeleflex Medical·Product code CAH·2012-09-21
K120943 — SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDERArthroCare Corporation·Product code MBI·2012-09-21
K121005 — ADIPREP ADIPOSE TRANSFER SYSTEMHarvest Technologies, Corp.·Product code MUU·2012-09-21
K121150 — ALMA LASERS FAMILY OF PIXEL RF TIPSAlma Lasers, Inc.·Product code GEI·2012-09-21
K121260 — TROOPER OXYGEN CONCENTRATORVbox, Inc.·Product code CAW·2012-09-21
K121558 — DIAZYME HSCRP POC TEST KITDiazyme Laboratories·Product code DCK·2012-09-21
K121568 — DALI SPINAL FIXATION SYSTEMAccel Spine·Product code NKB·2012-09-21
K121589 — BIOMET MICROFIXATION FACIAL PLATING SYSTEMBiomet Microfixation·Product code JEY·2012-09-21
K121674 — ASPIRE HD PLUS, ASPIRE HD-SFujifilm Medical System U.S.A., Inc.·Product code MUE·2012-09-21
K121773 — NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODEBiomerics·Product code 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.·Product code MSD·2012-09-21
K122026 — PRISM ACQUIRE PRISM PROCESS PRISM VIEWPrism Clinical Imaging, Inc.·Product code LNH·2012-09-21
K122089 — OSTIAL PRO STENT POSITIONING SYSTEMMerit Medical Systems, Inc.·Product code DQX·2012-09-21
K122109 — AQUILION ONE VISION, V4.90Toshiba America Medical Systems, In.C·Product code JAK·2012-09-21
K122327 — VOLUSON E6/E8/E8EXPERT/E10GE Healthcare·Product code IYN·2012-09-21
K113282 — CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIORiemser Arzeimittel AG·Product code LYC·2012-09-20
K113720 — RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3Randox Laboratories, Ltd.·Product code 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.·Product code MST·2012-09-20
K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)Inovise Medical, Inc.·Product code MLO·2012-09-20
K120501 — CHAMP CHAMP TRANSITConvaid Products, Inc.·Product code IOR·2012-09-20
K120867 — VIPER AND EXPEDIUM NAVIGATED INSTRUMENTSMedos International SARL·Product code OLO·2012-09-20
K121056 — METS MODULAR PROXIMAL FEMURStanmore Implants Worldwide , Ltd.·Product code JDI·2012-09-20
K121262 — MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READYMedefil, Inc.·Product code NGT·2012-09-20
K121590 — VESTIBULAR ANALYSIS APPARATUSCapacity Sports, LLC·Product code LXV·2012-09-20
K121676 — 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTGe Medical Systems, LLC·Product code LNH·2012-09-20
K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.·Product code FCW·2012-09-20
K121729 — E-CUBE 7Alpinion Medical Systems Co., Ltd.·Product code IYN·2012-09-20
K121850 — Typhoon(TM) Facet Screw Fixation SystemChoicespine, LP·Product code 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·Product code LZC·2012-09-20
K122021 — STERISPINE LC CAGESafe Orthopaedics·Product code MAX·2012-09-20
K122373 — NEOMED ORAL/ENTERAL SYRINGENeomed, Inc.·Product code FMF·2012-09-20
K122378 — NEXTGEN ALTIUS OCT SYSTEMBiomet Spine (Aka Ebi, LLC)·Product code KWP·2012-09-20
K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)Orthofix Srl·Product code KTW·2012-09-20
K122545 — CG+ ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.)·Product code LJS·2012-09-20
K122558 — ULTRASAFE PASSIVE NEEDLE GUARDSafety Syringes, Inc.·Product code MEG·2012-09-20
K120018 — MINDCHILD MERIDIAN FETAL HEART RATE MONITORMindchild Medical·Product code HGM·2012-09-19
K120288 — ORTHOCAD SOFTWARE OPTIONEsaote, S.p.A.·Product code LLZ·2012-09-19
K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEMNihon Kohden Corp.·Product code GWF·2012-09-19
K120405 — WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIRWalk on Wheels Australia Pty, Ltd.·Product code ITI·2012-09-19
K120450 — SLEEP PROFILERAdvanced Brain Monitoring, Inc.·Product code OLZ·2012-09-19
K120644 — MERIT HYDROPHILIC GUIDE WIREMerit Medical Systems, Inc.·Product code DQX·2012-09-19
K120657 — MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORSMasimo Corporation·Product code DQA·2012-09-19
K120968 — POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)Tangshan Zhonghong Pulin Plastic Co.,Ltd·Product code LYZ·2012-09-19
K121029 — METS MODULAR DISTAL FEMURStanmore Implants Worldwide , Ltd.·Product code KRO·2012-09-19
K121055 — METS MODULAR TOTAL FEMURStanmore Implants Worldwide , Ltd.·Product code JDI·2012-09-19
K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation·Product code LFR·2012-09-19
K121302 — BIOMET MICROFIXATION STERNAL CLOSURE SYSTEMBiomet Microfixation·Product code HRS·2012-09-19
K121689 — VITASCAN LT SCANMASTERVitacon Medical, Inc.·Product code IYO·2012-09-19
K121917 — PENUMBRA EMBOLECTOMY ASPIRATION SYSTEMPenumbra, Inc.·Product code QEW·2012-09-19
K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTNanosphere, Inc.·Product code PAM·2012-09-19
K122563 — MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNELHologic, Inc.·Product code HIH·2012-09-19
K122622 — ENDURAMESHLucero Medical, LLC·Product code MQP·2012-09-19
K110949 — BICERA (TM) RESORBABLE BONE SUBSTITUTEWiltrom Corporation Limited·Product code MQV·2012-09-18
K120107 — SCKOONCUPSckoon, Inc.·Product code HHE·2012-09-18
K121519 — ISIGHTC&E GP Specialists, Inc.·Product code LPL·2012-09-18
K121614 — NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETERBoston Scientific Corp·Product code LJE·2012-09-18
K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson and Company·Product code GQG·2012-09-18
K122591 — CLYDESDALE SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code MAX·2012-09-18
K113742 — KMC KYPHOPLASTY SYSTEMShanghai Kinetic Medical Co., Ltd.·Product code NDN·2012-09-17

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