FDA 510(k) clearances — page 431

176,542 clearances on record, most recent first.

Clearances — page 431

43,001–43,100 of 176,542

K123363 — SUPER STAPLE(TM) CLASSICMetric Medical Devices, Inc.·Product code JDR·2013-01-03
K123439 — NEO ERCP GUIDEWIRENeometrics, Inc.·Product code OCY·2013-01-03
K123452 — TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CMStryker·Product code DQY·2013-01-03
K123712 — RETRACTA DETACHABLE EMBOLIZATION COILCook Incorporated·Product code KRD·2013-01-03
K123759 — CG+ ARROW PICC POWERED BY ARROW VPS STYLETArrow International, Inc. (Subsidiary of Teleflex·Product code LJS·2013-01-03
K121296 — INTERVENTIONAL WORKSPOTPhilips Medical Systems Nederland B.V.·Product code LLZ·2013-01-02
K122273 — MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.·Product code MRC·2013-01-02
K122457 — GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONSGE Healthcare·Product code OWB·2013-01-02
K123877 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNSurgical Specialties Corp. Dba Angiotech·Product code NEW·2013-01-02
K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTDiaSorin, Inc.·Product code CIB·2013-01-01
K122919 — DIGITAL FLAT PANEL X-RAY DETECTOR11417PCARayence Co., Ltd.·Product code MQB·2013-01-01
K122111 — RESPIRONICS SIMPLYCLEAR DEVICERespironics, Inc.·Product code SDT·2012-12-31
K122481 — LIPIVIEW OCULAR SURFACE INTERFEROMETERTearscience, Inc.·Product code HKI·2012-12-31
K121007 — NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1Delta Med Srl·Product code FOZ·2012-12-28
K121297 — ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARSignature Orthopaedics Pty, Ltd.·Product code LPH·2012-12-28
K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC·Product code KHE·2012-12-28
K122474 — LANSINOH POWERED ELECTRIC BREAST PUMPLansinoh Laboratories Saglik Gerecleri Tasarim San·Product code HGX·2012-12-28
K122764 — RAPID STRAND RXMedi-Physics, Inc.·Product code KXK·2012-12-28
K123167 — DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEMMedos International SARL·Product code KWQ·2012-12-28
K123357 — ONQ RTSOncology Systems, Inc.·Product code MUJ·2012-12-28
K120490 — QUICK SAMPLER HOLDERNipro Medical Corporation·Product code JKA·2012-12-27
K121549 — NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUESiam Sempermed Corp., Ltd.·Product code LZA·2012-12-27
K121653 — INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORSCarl Zeiss Meditec, Inc.·Product code JAD·2012-12-27
K121661 — EZ-ASSIST-FILLAssist Fill, LLC·Product code PCM·2012-12-27
K121693 — A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)Sapphire Medical Group, Inc.·Product code MAX·2012-12-27
K121710 — XPERT CT/NGCepheid·Product code LSL·2012-12-27
K122039 — KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS BKettenbach GmbH & Co. KG·Product code EBG·2012-12-27
K122134 — FLEXLITE CAMERASpine View, Inc.·Product code HRX·2012-12-27
K122749 — PRESTIGE-MOBIEPrestige Sporting Goods Co. , Ltd.·Product code INI·2012-12-27
K122784 — NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHTBioness, Inc.·Product code GZI·2012-12-27
K122909 — SYNGO SINGLE SOURCE DUAL ENGERYSiemens Medical Systems, Inc.·Product code JAK·2012-12-27
K123091 — VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3TImris, Inc.·Product code MOS·2012-12-27
K123419 — EVA SELECT DIGITAL DENTAL IMAGING SYSTEMAfp Imaging Corp.·Product code MUH·2012-12-27
K123526 — CLEARREAD +CONFIRMRiverain Technologies·Product code LLZ·2012-12-27
K123591 — FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)Medtronic Cryocath, LP·Product code DRA·2012-12-27
K123663 — LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAKBio-Rad Laboratories·Product code JJY·2012-12-27
K123683 — NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITORAerocrine AB·Product code MXA·2012-12-27
K123017 — STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324Advanced Sterilization Products·Product code FRC·2012-12-26
K112898 — DELTA TT CUPS, DELTA TT LINERS, BONE SCREWSLima Corporate S.P.A.·Product code LPH·2012-12-21
K113010 — FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATORFamidoc Technology Co., Ltd.·Product code IPF·2012-12-21
K113023 — STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZERNxstage Medical, Inc.·Product code KDI·2012-12-21
K120391 — MR4500 WHEELCHAIRWardray Premise, Ltd.·Product code IOR·2012-12-21
K120475 — ANESTHESIA CONDUCTION NEEDLESShanghai Samedical & Plastic Instruments Co., Ltd.·Product code BSP·2012-12-21
K120793 — Z-LOOK3 EVO SLMZ-Systems AG·Product code DZE·2012-12-21
K120822 — STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, STInstitut Straumann AG·Product code NHA·2012-12-21
K120948 — PREXION 3DThe Yoshida Dental Mfg. Co., Ltd.·Product code OAS·2012-12-21
K121003 — ABBOTT PLEX-ID FLU ASSAYAbbott Laboratories·Product code OCC·2012-12-21
K121077 — NHANCERImds Operations B.V.·Product code DQY·2012-12-21
K121555 — CENTURION VISION SYSTEMAlcon Laboratories, Inc.·Product code HQC·2012-12-21
K122106 — SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLEVeran Medical Technologies, Inc.·Product code JAK·2012-12-21
K122142 — GLOOKO LOGBOOK CHARTSGlooko, Inc.·Product code NBW·2012-12-21
K122414 — AB COMMAND DUAL CHANNEL FITNESS BELTLeto Enterprises Incorporation·Product code NGX·2012-12-21
K122609 — VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) FVenous Health Systems, Inc.·Product code JOW·2012-12-21
K122616 — PANTHER OIS/R & V MODEL VERSION 2.0Prowess, Inc.·Product code IYE·2012-12-21
K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLEArrow International, Inc.·Product code CAZ·2012-12-21
K122717 — FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASKTiger Medical Products, Ltd.·Product code FXX·2012-12-21
K122897 — SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645Invivo Corporation·Product code MOS·2012-12-21
K122944 — GEMORE TRUE SINE INTERFERENTIAL STIMULATORGemore Technology Co, Ltd.·Product code LIH·2012-12-21
K122948 — GEM-STIM COMBO STIMULATORGemore Technology Co, Ltd.·Product code GZJ·2012-12-21
K122961 — WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)Guangzhou Wondfo Biotech Co., Ltd.·Product code DKZ·2012-12-21
K123000 — INTEGRA TOTAL FOOT SYSTEMSIntegra LifeSciences Corporation·Product code HRS·2012-12-21
K123092 — CERAMIN BRACKETS ZTomy, Inc.·Product code NJM·2012-12-21
K123172 — KOGENT BIPOLAR FORCEPSKatalyst Surgical, LLC·Product code GEI·2012-12-21
K123191 — XPERT FLUCepheid·Product code OCC·2012-12-21
K123260 — DETACHATIP IIIConmed Corporation·Product code GEI·2012-12-21
K123341 — ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTONArthrex, Inc.·Product code MBI·2012-12-21
K123611 — E-CUBE 7Alpinion Medical Systems Co., Ltd.·Product code IYN·2012-12-21
K123616 — PORTABLE ULTRASONIC DIAGNOSTIC SYSTEMSonoscape Company Limited·Product code IYO·2012-12-21
K123637 — HAMILTON-C3Hamilton Medical AG·Product code CBK·2012-12-21
K123669 — TRANSTEK WRIST BLOOD PRESSURE MONITORZhongshan Transtek Electronics Co., Ltd.·Product code DXN·2012-12-21
K123729 — VERSARATE FLOW RATE CONTROLEREmed Technologies Corporation·Product code FPA·2012-12-21
K123754 — CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEMPhilips Ultrasound, Inc.·Product code IYN·2012-12-21
K123771 — KYPHON EXPRESS II INFLATABLE BONE TAMPSMedtronic·Product code HRX·2012-12-21
K123773 — X-TRA BASEVoco GmbH·Product code EBF·2012-12-21
K123836 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNSurgical Specialties Corp. Dba Angiotech·Product code GAM·2012-12-21
K111105 — CURASAN OSSEOLIVE DENTALCurasan AG·Product code LYC·2012-12-20
K111189 — SYNTEC DENTAL IMPLANTSyntec Scientific Corp.·Product code DZE·2012-12-20
K112910 — AP 72OS SEMI-AUTOMATED INSTRUMENTHitachi Chemical Diagnostics, Inc.·Product code DHB·2012-12-20
K120357 — ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp.·Product code FEB·2012-12-20
K121027 — DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHDiamond Diagnostics, Inc.·Product code JIT·2012-12-20
K121046 — STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITKronus Market Development Associates, Inc.·Product code PCG·2012-12-20
K121268 — WANDY DISPERSVIE ELECTRODEBio-Med USA, Inc.·Product code ODR·2012-12-20
K121405 — PANOPTICWelch Allyn, Inc.·Product code HKI·2012-12-20
K121582 — INVENDO C25 COLONOSCOPY SYSTEMInvendo Medical Gbmh·Product code FDF·2012-12-20
K121913 — REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETERStryker Sustainability Solutions, Inc.·Product code OWQ·2012-12-20
K121998 — HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCEDChangzhou Holymed Products Co., Ltd.·Product code FYA·2012-12-20
K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTERIntersurgical, Inc.·Product code CCK·2012-12-20
K122208 — EXTERNAL FIXATOR SYSTEMChristopher D. Endara·Product code NDK·2012-12-20
K122435 — NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical Corporation·Product code LFR·2012-12-20
K122575 — BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIBausch & Lomb, Inc.·Product code LPL·2012-12-20
K122658 — FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009Femasys, Inc.·Product code PCF·2012-12-20
K122927 — OXICARE FINGERTIP PULSE OXIMETERDelbio Incorporated·Product code DQA·2012-12-20
K122975 — GKS PRIME FLEX CR TOTAL KNEE SYSTEMPermedica·Product code JWH·2012-12-20
K122991 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.·Product code JWH·2012-12-20
K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.·Product code DFC·2012-12-20
K123085 — FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE3M Company·Product code DWL·2012-12-20
K123093 — STABILINK MIS SPINAL FIXATION SYSTEMSouthern Spine, LLC·Product code KWP·2012-12-20
K123168 — Q-PLUS T+ IPL LASER SYSTEMQuanta System Spa·Product code GEX·2012-12-20
K123255 — g.HIampG.Tec Medical Engineering GmbH·Product code GWL·2012-12-20
K123291 — TRUEBEAMVarian Medical Systems, Inc.·Product code IYE·2012-12-20

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