FDA 510(k) clearances — page 401

176,542 clearances on record, most recent first.

Clearances — page 401

40,001–40,100 of 176,542

K122932 — SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORTFogless International AB·Product code JOH·2013-12-23
K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESKeeler, Ltd.·Product code HRN·2013-12-23
K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.·Product code MID·2013-12-23
K131901 — IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N23B Medical, Inc.·Product code BZD·2013-12-23
K132310 — ASCOTBackroads Consulting, Inc.·Product code KWQ·2013-12-23
K132386 — TOTALSHIELD SURGICAL HELMET SYSTEMZimmer, Inc.·Product code FYA·2013-12-23
K132500 — CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATEDCure Medical, LLC·Product code EZD·2013-12-23
K132854 — EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEARYung Sheng Optical Co., Ltd.·Product code LPL·2013-12-23
K133127 — LIPIFLOW THERMAL PULSATION SYSTEMTearscience, Inc.·Product code ORZ·2013-12-23
K133133 — LAURIMED POLYPVAC MICRODEBRIDERLaurimed, LLC·Product code ERL·2013-12-23
K133627 — AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENSCooperVision, Inc.·Product code LPL·2013-12-23
K133634 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETCook, Inc.·Product code LJS·2013-12-23
K122162 — AGGREGUIDEAggredyne, Inc.·Product code JOZ·2013-12-20
K123006 — AIR BARRIER SYSTEM (ABS)Nimbic Systems, Inc.·Product code ORC·2013-12-20
K130052 — TONE-A-MATICTone-A-Matic International, Inc.·Product code IPF·2013-12-20
K130082 — GENPRIME DRUGS OF ABUSE READER SYSTEMGenprime, Inc.·Product code DKZ·2013-12-20
K130208 — BERNOULLI ENTERPRISE SOFTWARECardiopulmonary Corp.·Product code MHX·2013-12-20
K130284 — ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEMACON Laboratories, Inc.·Product code NBW·2013-12-20
K130691 — ELECTROTHERAPY DEVICE (COMBO UNIT)Guangzhou Finecure Medical Equipment Co.,Ltd·Product code IPF·2013-12-20
K131510 — POLYDIMETHYLSILOXANE IMPRESSION MATERIALBlackwell Device Consulting·Product code ELW·2013-12-20
K131765 — ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEMConmed Corporation·Product code DSB·2013-12-20
K131879 — KC 300 SURGICAL MASKKimberly-Clark Corp.·Product code FXX·2013-12-20
K131933 — ELECTRONIC PULSE MASSAGERGurin Products, LLC·Product code NUH·2013-12-20
K131935 — ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZERNipro Medical Corporation·Product code KDI·2013-12-20
K131953 — IMAGE1 SPIESKARL STORZ Endoscopy-America, Inc.·Product code FET·2013-12-20
K132026 — V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21Mindray DS USA, Inc.·Product code MHX·2013-12-20
K132067 — MULTI ANGLED ABUTMENT SYSTEMHiossen, Inc.·Product code NHA·2013-12-20
K132243 — BARLE TISSUE ADHESIVE 2Advanced Medical Solutions (Plymouth), Ltd.·Product code MPN·2013-12-20
K132329 — NIVATOPIC PLUSNivagen Pharmaceuticals, Inc.·Product code FRO·2013-12-20
K132342 — XVWEBApteryx, Inc.·Product code LLZ·2013-12-20
K132428 — IDEALJiangsu Ideal Medical Science & Technology Co., LT·Product code HSB·2013-12-20
K132530 — GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)Datex-Ohmeda, Inc.·Product code BSZ·2013-12-20
K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITThe Binding Site·Product code PCN·2013-12-20
K132646 — SUNETICS CLINICAL BIO-STIMULATION LASERSunetics International Marketing Group, LLC·Product code OAP·2013-12-20
K132652 — VIA MICROCATHETER, VIA PLUS MICROCATHETERSequent Medical, Inc.·Product code DQY·2013-12-20
K132671 — STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEMStryker Corporation·Product code JCX·2013-12-20
K132708 — BIOMARC FIDUCIAL MARKERCarbon Medical Technologies, Inc.·Product code NEU·2013-12-20
K132715 — BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENSBausch & Lomb, Incorporated·Product code LPL·2013-12-20
K132776 — SEAL BIOPSY VALVE - REUSABLEEndochoice, Inc.·Product code OCX·2013-12-20
K132790 — INFIX ANTERIOR LUMBAR SYSTEMZimmer Spine, Inc.·Product code MAX·2013-12-20
K132887 — AIRFIT N10Resmed, Ltd.·Product code BZD·2013-12-20
K132917 — OCULAR FORCE GAUGEOcular Therapeutix, Inc.·Product code HKY·2013-12-20
K132998 — WANDY SELF-ADHESIVE ELECTRODESWandy Rubber Industrial Co., Ltd.·Product code GXY·2013-12-20
K133052 — AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEMNuvasive, Inc.·Product code PEK·2013-12-20
K133078 — K-ETCHANT SYRINGE; NEEDLE TIP (E)Kuraray Noritake Dental, Inc.·Product code KLE·2013-12-20
K133169 — MESO TENDON MATRIXKensey Nash Corporation Dba Dsm Biomedical·Product code OWY·2013-12-20
K133281 — NEOTRACT UROLIFT SYSTEMNeotract, Inc.·Product code PEW·2013-12-20
K133338 — LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H·Product code GEI·2013-12-20
K133367 — ORTHOVIS PREOPERATIVE PLANCustom Orthopaedic Solutions·Product code LLZ·2013-12-20
K133423 — REST ASSURED EXTRA COMFORT NITE PROTECTORRanir, LLC·Product code OBR·2013-12-20
K133503 — AMPLIVUE GBS ASSAYQuidel Corporation·Product code NJR·2013-12-20
K133513 — MULTI-STAGE SNAREUnited States Endoscopy Group, Inc.·Product code FDI·2013-12-20
K133563 — PATHASSIST LIGHT SEEKEREntellus Medical, Inc.·Product code LRC·2013-12-20
K133566 — ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSBoston Scientific Corp·Product code MCW·2013-12-20
K133569 — TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CMBard Peripheral Vascular, Inc.·Product code OZT·2013-12-20
K133587 — PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300St. Jude Medical Systems AB·Product code DRG·2013-12-20
K133605 — BD MAX MRSA XT, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc.·Product code NQX·2013-12-20
K133626 — AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35MicroVention, Inc.·Product code KRD·2013-12-20
K133630 — GMK SHORT STEMMedacta International·Product code JWH·2013-12-20
K133641 — CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILEVolcano Corporation·Product code IYO·2013-12-20
K133650 — CAPSTONE SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code MAX·2013-12-20
K123030 — COMPRESSOR NEBULIZER MODEL MCN-S600XXDongguan Aidisy Machinery & Electronic Equipment C·Product code CAF·2013-12-19
K123209 — SOFTVUEDelphinus Medical Technologies, Inc.·Product code IYO·2013-12-19
K124064 — YOUNG AGAINEspansione Marketing S.P.A·Product code OHS·2013-12-19
K130579 — PHYSOFT AMSPhysicians Software Systems, LLC·Product code MQS·2013-12-19
K130611 — ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBEXeridiem Medical Devices·Product code KNT·2013-12-19
K131381 — ELISIO-H HEMODIALYZERNipro Medical Corporation·Product code KDI·2013-12-19
K132086 — ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEMACON Laboratories, Inc.·Product code NBW·2013-12-19
K132368 — VAPOR CERAMIC BRACKETOrthodontic Design and Production, Inc.·Product code NJM·2013-12-19
K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLSBiokit, S.A.·Product code JIT·2013-12-19
K132623 — MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIREMedtronic·Product code DQX·2013-12-19
K132794 — SMARTVEST AIRWAY CLEARANCE SYSTEMElectromed, Inc.·Product code BYI·2013-12-19
K132837 — LINA POWERBLADE PLUSLina Medical Aps·Product code GEI·2013-12-19
K132952 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)MicroVention, Inc.·Product code HCG·2013-12-19
K133346 — SMARTLOG DIABETES MANAGEMENT SOFTWAREI-Sens, Inc.·Product code NBW·2013-12-19
K133475 — STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWSNexxt Spine, LLC·Product code KWQ·2013-12-19
K133511 — 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)Jvckenwood Corporation·Product code LLZ·2013-12-19
K133561 — VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATHAngioDynamics, Inc.·Product code GEX·2013-12-19
DEN110009 — RESTLESS LEG DEVICEMary M. Sorg (An Individual) Dba PJ Sleeper'S·Product code OTX·2013-12-18
DEN110011 — SYMPHONY DEVICESensory Medical, Inc.·Product code OVP·2013-12-18
DEN130007 — AXIOS STENT AND DELIVERY SYSTEMXlumena, Inc.·Product code PCU·2013-12-18
K130797 — LUCO HYBRID OSA APPLIANCELuco Hybrid Osa Appliance, Inc.·Product code LRK·2013-12-18
K131379 — EARLYSENSEEarlysense, Ltd.·Product code BZQ·2013-12-18
K131664 — COPRA TEMP PMMA-DISKWhite Peaks Dental Systems GmbH & Co. KG·Product code EBG·2013-12-18
K131758 — SURGEN UPollogen, Ltd.·Product code GEI·2013-12-18
K132186 — OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2Optomed OY·Product code HKI·2013-12-18
K132418 — COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2Roche Diagnostics·Product code JGS·2013-12-18
K132876 — ARIX HAND LOCKING SYSTEMJeil Medical Corporation·Product code HRS·2013-12-18
K132878 — M.U.S.T. EXTENSIONMedacta International·Product code NKB·2013-12-18
K132992 — TI STAR IMPLANT SYSTEMT-Plus Implant Tech. Co., Ltd.·Product code DZE·2013-12-18
K133440 — AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSIONStryker Trauma AG·Product code HWC·2013-12-18
K133460 — APTUS CANNULATED COMPRESSION SCREWSMedartis AG·Product code HWC·2013-12-18
K133586 — VISI MOBILE MONITIORING SYSTEMSotera Wireless, Inc.·Product code MWI·2013-12-18
K133637 — ALERE INFLUENZA A & B TESTAlere Scarborough, Inc D/B/A Binax, Inc.·Product code PSZ·2013-12-18
K130652 — VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERTConsensus Orthopedics, Inc.·Product code OQG·2013-12-17
K130736 — BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISHelix Medical, LLC·Product code LRC·2013-12-17
K131919 — ZOLL EPCR IOSZOLL Medical Corporation·Product code DXJ·2013-12-17
K132218 — PERFIX ILIAC SCREW SYSTEMU&I Corporation·Product code MNH·2013-12-17
K132264 — PRIMADO2 TOTAL SURGICAL SYSTEMNakanishi, Inc.·Product code HBC·2013-12-17
K132340 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1Erbe USA, Inc.·Product code FEQ·2013-12-17

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