FDA 510(k) clearances — page 375

176,542 clearances on record, most recent first.

Clearances — page 375

37,401–37,500 of 176,542

K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGMRoche Diagnostics·Product code LFZ·2014-10-24
K142574 — 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,Depuy Mitek, A Johnson & Johnson Company·Product code MBI·2014-10-24
K142727 — CrossCLIP Implant SystemOrthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems·Product code JDR·2014-10-24
K142784 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive SurfaceMedtronic, Inc.·Product code DTZ·2014-10-24
K131737 — SUPERNOVA C5 MRI SYSTEMLiaoning Kampo Medical System Co., Ltd.·Product code LNH·2014-10-23
K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6Medtronic, Inc.·Product code DRY·2014-10-23
K140205 — PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMTeleflexmedical, Inc.·Product code CAC·2014-10-23
K140754 — COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEMCooperSurgical, Inc.·Product code HEX·2014-10-23
K141125 — U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLEHandpiece Headquarters·Product code EGS·2014-10-23
K141325 — TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERATopcon Corp.·Product code HKI·2014-10-23
K141339 — ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIREAsahi Intecc Co., Ltd.·Product code DQX·2014-10-23
K141560 — ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICEETHICON, Inc.·Product code FTL·2014-10-23
K141816 — HEMOPOREPolyganics B.V.,·Product code LYA·2014-10-23
K141860 — RAYSTATIONRaysearch Laboratories AB·Product code MUJ·2014-10-23
K142101 — ABACUS (TM) SPACER SYSTEMSpine Wave, Inc.·Product code MAX·2014-10-23
K142359 — Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd.·Product code DXC·2014-10-23
K142556 — Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc.·Product code FGB·2014-10-23
K142603 — Stryker Precision HD Camera SystemStryker Endoscopy·Product code GCJ·2014-10-23
K142698 — PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.·Product code MQB·2014-10-23
K142755 — Siemens 3.0 Blanket Array CoilResonance Innovations, LLC·Product code MOS·2014-10-23
K142757 — LiNA PowerBlade Plus HCLina Medical Aps·Product code GEI·2014-10-23
K142876 — ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.·Product code IYN·2014-10-23
K133849 — VANTERA CLINICAL ANALYZERLiposcience·Product code NSU·2014-10-22
K140251 — UNIVERSAL DIGITAL INTERFACE 2, UDI 2Meridian Medical Systems, LLC·Product code MQB·2014-10-22
K141211 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTSPrismatik Dentalcraft, Inc.·Product code NHA·2014-10-22
K141491 — SOLITAIRE 2 REVASCULARIZATION DEVICEMicro Therapeutics, Inc. d/b/a ev3 Neurovascular·Product code NRY·2014-10-22
K141544 — ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEMZimmer Dental, Inc.·Product code NHA·2014-10-22
K141603 — Ultra Silver DressingsMilliken Healthcare Products, LLC·Product code FRO·2014-10-22
K141658 — LIGHT SCALPELLightscalpel, LLC·Product code GEX·2014-10-22
K141723 — UPCERA COLORING LIQUID (I AND II )Liaoning Upcera Co., Ltd.·Product code EIH·2014-10-22
K141724 — UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKLiaoning Upcera Co., Ltd.·Product code EIH·2014-10-22
K141908 — DUAL SWITCHLaser Engineering, Inc.·Product code GEX·2014-10-22
K142281 — ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEMZimmer, Inc.·Product code HSB·2014-10-22
K142579 — Zimmer Periarticular Plating SystemZimmer, Inc.·Product code HRS·2014-10-22
K142602 — VALOR Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc·Product code HSB·2014-10-22
K142670 — Vericore Zirconia BlanksWhip Mix Corporation·Product code EIH·2014-10-22
K142708 — VERADIUS UNITYPhilips Medical Systems Nethrlands BV·Product code OWB·2014-10-22
K140197 — PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEMTeleflexmedical, Inc.·Product code CAC·2014-10-21
K141604 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2014-10-21
K141651 — SENSITITRE SUSCEPTIBILITY PLATESThermo Fisher Scientific·Product code JWY·2014-10-21
K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIREBoston Scientific Corp·Product code OCY·2014-10-21
K141904 — VIORA V-TOUCHViora , Ltd.·Product code GEI·2014-10-21
K142003 — FDR D-EVO II FLAT PANEL DETECTOR SYSTEMFujifilm Medical System U.S.A., Inc.·Product code MQB·2014-10-21
K142042 — ERCHONIA SHLErchonia Corporation·Product code OLI·2014-10-21
K142381 — Xia 3 Spinal SystemStryker Corp.·Product code NKB·2014-10-21
K132490 — SKORE AND MULTIPLE BRANDSTtk Protective Devices Limited (Formerly Ttk-Lig L·Product code HIS·2014-10-20
K140236 — AILERON INTERSPINOUS FIXATION SYSTEMLife Spine, Inc.·Product code PEK·2014-10-20
K140268 — SIMPLE T YOUTH NASAL MASKRespironics, Inc.·Product code BZD·2014-10-20
K140993 — IONOSTAR MOLARVoco GmbH·Product code EMA·2014-10-20
K142026 — SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICESpinefrontier, Inc.·Product code ODP·2014-10-20
K133360 — AERONEB SOLO; AERONEB SOLO ADAPTERAerogen, Ltd.·Product code CAF·2014-10-17
K140472 — BONASTENT TRACHEAL / BRONCHIALEndochoice, Inc.·Product code JCT·2014-10-17
K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORTCedic S.R.L.·Product code PIO·2014-10-17
K140728 — MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PRDitron Precision, Ltd.·Product code DZE·2014-10-17
K140783 — HALO AMBULATORY INFUSION SYSTEMZyno Medical, LLC·Product code FRN·2014-10-17
K140929 — Z1 CPAP SYSTEMHuman Design Medical, LLC·Product code BZD·2014-10-17
K141152 — ADVANTAGEStevenson Industries, Inc.·Product code BZD·2014-10-17
K141165 — MATRIXWAVE MMF SYSTEMSynthes (USA) Products, LLC·Product code JEY·2014-10-17
K141242 — GLIDE DEVICEHome Skinovations , Ltd.·Product code OHT·2014-10-17
K141335 — EXPEL APD DRAINAGE CATHETER SYSTEMBoston Scientific Corp·Product code FGE·2014-10-17
K141344 — EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEMBoston Scientific Corp·Product code FAD·2014-10-17
K141426 — ELECSYS FOLATE IIIRoche Diagnostics·Product code CGN·2014-10-17
K141579 — EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREEEco Medi Glove Sdn. Bhd.·Product code LZA·2014-10-17
K141600 — NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KITPioneer Surgical Technology, Inc. (Rti Surgical, I·Product code MQV·2014-10-17
K141742 — ARDO CARUM AND CALYPSO POWERED BREAST PUMPSArdo Medical AG·Product code HGX·2014-10-17
K141917 — UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEARUnicon Optical Co., Ltd.·Product code LPL·2014-10-17
K142091 — PARIETENE MACROPOROUS MESHSofradim Production·Product code FTL·2014-10-17
K142096 — T-PIECE RESUSCITATORMercury Medical·Product code BTL·2014-10-17
K142220 — Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)Nova Biomedical Corporation·Product code CHL·2014-10-17
K142252 — XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.·Product code LRC·2014-10-17
K142267 — Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.·Product code LJS·2014-10-17
K142589 — Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TLTitan Spine, LLC·Product code MAX·2014-10-17
K142636 — Merit 10mL SyringeMerit Medical Systems, Inc.·Product code FMF·2014-10-17
K142660 — Antegrade LeMills ValvulotomeLeMaitre Vascular, Inc.·Product code MGZ·2014-10-17
K133390 — NDX DORSAL APPLIANCEInstitute For Quality Resource Management·Product code LRK·2014-10-16
K133488 — PIEZOMEDW&H Dentalwerk Buermoos GmbH·Product code DZI·2014-10-16
K133677 — SYNGO CT SINGLE SOURCE DUAL ENERGYSiemens Medical Solutions USA, Inc.·Product code JAK·2014-10-16
K140023 — ELEVATIONPdg Product Design Group, Inc.·Product code IOR·2014-10-16
K140543 — PRELUDEEASE HYDROPHILIC SHEATH INTRODUCERMerit Medical Systems, Inc.·Product code DYB·2014-10-16
K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERCDima Italia Srl·Product code NHJ·2014-10-16
K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEMBoston Scientific Corporation·Product code JCT·2014-10-16
K141753 — AQUARIUS NASAL FEEDING TUBEDegania Silicone , Ltd.·Product code PIF·2014-10-16
K141801 — HAWKONE DIRECTIONAL ATHERECTOMY SYSTEMCovidien, LLC·Product code MCW·2014-10-16
K142184 — DX-D IMAGING PACKAGEAgfa Healthcare N.V.·Product code MQB·2014-10-16
K142280 — Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)Healgen Scientific,, LLC·Product code DJG·2014-10-16
K142618 — Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound SystemHitachi Aloka Medical America, Inc.·Product code ITX·2014-10-16
K142653 — G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.·Product code MBI·2014-10-16
K131987 — MULTIPULSE HOPLUSAsclepion Laser Technologies GmbH·Product code GEX·2014-10-15
K134009 — UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONALMedtek Lighting·Product code FTC·2014-10-15
K140025 — AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSESPegavision Corporation·Product code LPL·2014-10-15
K140470 — OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBEROberon GmbH Fiber Technologies·Product code GEX·2014-10-15
K141776 — STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICESETHICON, Inc.·Product code NEW·2014-10-15
K141865 — DANAAnthrotronix, Inc.·Product code LQD·2014-10-15
K141954 — XCEL 455 SLIT LAMPReichert, Inc.·Product code HJO·2014-10-15
K142095 — RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEMRenovis Surgical Technologies, Inc.·Product code OVD·2014-10-15
K142193 — COGENT MED-LIF XLCogent Spine, LLC·Product code MAX·2014-10-15
K142346 — Urine/CSF Albumin, Urine/CSF Albumin CalibratorBeckman Coulter Ireland, Inc.·Product code DCF·2014-10-15
DEN130044 — INFLOW INTRAURETHRAL VALVE-PUMPVesiflo, Inc.·Product code PIH·2014-10-14
K142277 — JULIET POSpineart·Product code MAX·2014-10-14
K142616 — PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.·Product code LJS·2014-10-14

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