FDA 510(k) clearances — page 414

176,542 clearances on record, most recent first.

Clearances — page 414

41,301–41,400 of 176,542

DEN130010 — VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)Abbott Molecular, Inc.·Product code PDO·2013-07-29
K122091 — COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAYCook, Inc.·Product code MPB·2013-07-29
K123831 — OPHTACATH KITFrance Chirurgae Instrumentation·Product code OKS·2013-07-29
K130059 — ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAPIbi Israel Biomedical Innovations , Ltd.·Product code PBQ·2013-07-29
K130381 — ANGIOJET ULTRA POWER PULSE KITMedrad, Inc.·Product code QEW·2013-07-29
K130855 — PTFE SUPER SHEATH INTRODUCERMartech Medical Products·Product code DYB·2013-07-29
K131182 — MULTIFIX S KNOTLESS FIXATION DEVICEArthocare Corporation·Product code MBI·2013-07-29
K131361 — WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKETCovidien·Product code DWJ·2013-07-29
K131710 — MERIT HYDROPHILIC GUIDE WIREMerit Medical Systems, Inc.·Product code DQX·2013-07-29
K121445 — TETRACHROME REAGENTS AND TETRACXP SYSTEMBeckman Coulter, Inc.·Product code OYE·2013-07-26
K122659 — VDRIVE W/V-SONOStereotaxis, Inc.·Product code DQX·2013-07-26
K123721 — GMK REVISION EXTENSIONMedacta International·Product code JWH·2013-07-26
K123768 — RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation·Product code NZA·2013-07-26
K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERSauflon Pharmaceuticals, Ltd.·Product code MVN·2013-07-26
K130410 — DENTAL UNIT WITH CHAIRXianyang North West Medical Instrument (Group) Co.·Product code EIA·2013-07-26
K130478 — SUSTAIN AND SUSTAIN RADIOLUCENT SPACERSGlobus Medical, Inc.·Product code MAX·2013-07-26
K130500 — CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTSebia·Product code CEF·2013-07-26
K130623 — BARRX CHANNEL RFA ENDOSCOPIC CATHETERCovidien, LLC·Product code KNS·2013-07-26
K130680 — ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINSDentsoll, Inc.·Product code EBI·2013-07-26
K130785 — SEER 1000Getemed Medizin- Und Informationstechnik AG·Product code MWJ·2013-07-26
K131117 — ZIRMON SERIESKuwotech Co., Ltd.·Product code EIH·2013-07-26
K131264 — KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWSGebr. Brasseler GmbH & Co. KG·Product code HWC·2013-07-26
K131448 — 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTIONKoelis·Product code LLZ·2013-07-26
K131549 — CHEMOLOCK, CHEMOLOCK PORTIcu Medical, Inc.·Product code ONB·2013-07-26
K131595 — EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVMEurotrol B.V.·Product code JJY·2013-07-26
K131814 — AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETERAmeco Medical Industries·Product code MSD·2013-07-26
K131931 — CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TESTChemtron Biotech, Inc.·Product code LCX·2013-07-26
K131999 — HBA1C CONTROL, LEVEL 1 AND LEVEL 2Randox Laboratories, Ltd.·Product code JJX·2013-07-26
DEN130032 — XPERT MTB/RIF ASSAYCepheid·Product code PEU·2013-07-25
K123027 — CAPSTONE(R) SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code MAX·2013-07-25
K130001 — CARE SU01A SUCTION ASPIRATORFoshan Care Medical Technology Co., Ltd.·Product code JCX·2013-07-25
K130158 — M-SCANBio-Research Associates, Inc.·Product code KZM·2013-07-25
K130431 — COMPRESSYN BANDDallen Medical, Inc.·Product code JDQ·2013-07-25
K130706 — DUOFLEX COIL SUITE (1.5T)Mr Instruments, Inc.·Product code MOS·2013-07-25
K130859 — HAMMERTOE CORRECTION SYSTEMArthrosurface, Inc.·Product code HWC·2013-07-25
K131159 — SMARTRELIEFChattem, Inc.·Product code NUH·2013-07-25
K131475 — BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical·Product code HCG·2013-07-25
K131498 — IQQA-LIVER MULTIMODALITY SOFTWAREEdda Technology, Inc.·Product code LLZ·2013-07-25
K131620 — JONES-FX FRACTURE SYSTEMInstratek, Inc.·Product code HWC·2013-07-25
K131812 — SENSIS, SENSIS LITESiemens Medi Cal Solutions, Inc.·Product code DQK·2013-07-25
K131974 — HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)Depuy Mitek, A Johnson & Johnson Company·Product code MAI·2013-07-25
K123714 — EDWARDS EMBOL-X INTRODUCER SHEATHEdwards Lifesciences, LLC·Product code DYB·2013-07-24
K130125 — MTA CEMENTSS&C Polymer Silicon- Und Composite Spezialitaeten·Product code KIF·2013-07-24
K130305 — LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZELina Medical Aps·Product code HIN·2013-07-24
K130667 — POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGELPreventive Care, Inc.·Product code LYY·2013-07-24
K130962 — R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.·Product code JPK·2013-07-24
K131263 — XPERGUIDEPhilips Medical Systems Nederland B.V.·Product code OWB·2013-07-24
K131343 — REFORM PEDICLE SCREW SYSTEMSpinal USA·Product code MNI·2013-07-24
K131542 — NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTCNovabay Pharmaceuticals, Inc.·Product code FRO·2013-07-24
K131561 — SAM JUNCTIONAL TOURNIQUETSam Medical Products·Product code DXC·2013-07-24
K131690 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEMShenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code IYO·2013-07-24
K131742 — HEM-6131Omron Healthcare, Inc.·Product code DXN·2013-07-24
K131964 — BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLEMedtronic, Inc.·Product code DWA·2013-07-24
K132087 — PERCUNAV SYSTEMPhilips Health Care·Product code JAK·2013-07-24
K123631 — MFP-051GC America, Inc.·Product code EBF·2013-07-23
K123807 — SHARPSCANMedical Engineering Development Solutions, Inc.·Product code MMK·2013-07-23
K130207 — SPACELABS HEALTHCARE CARDIOEXPRESSSpacelabs Healthcare, Ltd.·Product code DPS·2013-07-23
K130648 — FORUM GLAUCOMA WORKPLACECarl Zeiss Meditec, AG·Product code NFJ·2013-07-23
K130702 — AIRSONETT AIR-4Airsonett AB·Product code FRF·2013-07-23
K130740 — NIGHTINGALE MONITORING SYSTEMZoe Medical, Inc.·Product code MWI·2013-07-23
K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMDentsply Intl., Inc.·Product code ELC·2013-07-23
K130986 — FRAG-LOC SYSTEMAcumed, LLC·Product code HTN·2013-07-23
K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEMSorin Group Deutschland GmbH·Product code DXJ·2013-07-23
K131822 — ULTRAEXTEND USWS-900A V2.1 AND V3.1Toshiba America Medical Systems, In.C·Product code LLZ·2013-07-23
K132062 — ESIE APPS SUITESiemens Medical Solutions USA, Inc.·Product code LLZ·2013-07-23
K130220 — MR CONDITIONAL PRESSON ELECTRODERhythmlink International, LLC·Product code GXZ·2013-07-22
K130750 — RHYTHMIA MAPPING SYSTEMRhythmia Medical, Inc.·Product code DQK·2013-07-22
K131191 — 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUSDepuy Mitek, A Johnson & Johnson Company·Product code HRX·2013-07-22
K131306 — IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICEBio Compression Systems, Inc.·Product code JOW·2013-07-22
K131572 — MICRO AMBULATORY ECG RECORDERDimetek Digital Medical Technologies, Ltd.·Product code DPS·2013-07-22
K123418 — GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.·Product code JSS·2013-07-21
K120510 — TRANSCENDSyneron Medical, Ltd.·Product code GEI·2013-07-19
K122988 — KLOCKNER DENTAL IMPLANT ABUTMENTSSOADCO, S.L.·Product code NHA·2013-07-19
K124055 — T1040 AKA AURAWAVEEndurance Therapeutics·Product code NUH·2013-07-19
K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of M·Product code BYJ·2013-07-19
K130079 — MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETERReflectance Medical, Inc.·Product code MUD·2013-07-19
K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,Technomed Europe·Product code GXZ·2013-07-19
K130658 — ELIXBO PM545Xbo Medical Systems Co., Ltd.·Product code LNH·2013-07-19
K130731 — STABILIZ FIXATION SYSTEM - SPL LOCKING SCREWStabiliz Orthopaedics, LLC·Product code HRS·2013-07-19
K131130 — NAVIGATION PINEvergreen Orthopedic Research Lab·Product code OLO·2013-07-19
K131203 — IHEALTH CLOUDAndon Health Co, Ltd.·Product code DXN·2013-07-19
K131332 — CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCERCardiosolutions, Inc.·Product code DYB·2013-07-19
K131811 — UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSUcp Biosciences, Inc.·Product code DKZ·2013-07-19
K123332 — NAOMI-CTLk Consulting Group·Product code OAS·2013-07-18
K130088 — PORT VIEW, DIGITAL X-RAY SENSOR SYSTEMGenoray Co., Ltd.·Product code MUH·2013-07-18
K130224 — ICTImris, Inc.·Product code JAK·2013-07-18
K130399 — CERTUS 140 CERTUSURGGT SURGICAL TOOLNeuwave Medical, Inc.·Product code NEY·2013-07-18
K131046 — VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)Venous Health Systems, Inc.·Product code JOW·2013-07-18
K131137 — 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)Jvckenwood Corporation·Product code LLZ·2013-07-18
K131179 — CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITORThoratec Corp·Product code DWA·2013-07-18
K131327 — BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEMBio Compression Systems, Inc.·Product code JOW·2013-07-18
K131467 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2013-07-18
K131688 — NEOCLOSE HASSON, NEOCLOSE UNIVERSALNeosurgical, Ltd.·Product code GCJ·2013-07-18
K131776 — ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3Randox Laboratories, Ltd.·Product code JJX·2013-07-18
K131805 — INPULSE LASERIncisive, Inc.·Product code GEX·2013-07-18
K131905 — SOLID GEL PADBluemtech·Product code MUI·2013-07-18
K113126 — ACRYLIC HERBST APPLIANCEGergens Orthodontic Lab·Product code LRK·2013-07-17
K123660 — 25-OH VITAMIN D ELISAEuroimmun US·Product code MRG·2013-07-17
K123753 — IMDX VANR FOR ABBOTT M2000Intelligent Medical Devices, Inc.·Product code NIJ·2013-07-17
K123787 — GREENCROSS SURGICAL MASKJingzhou Haixin Green Cross Medical Products Co.,L·Product code FXX·2013-07-17

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