FDA 510(k) clearances — page 433

176,542 clearances on record, most recent first.

Clearances — page 433

43,201–43,300 of 176,542

K123120 — LENSX LASER SYSTEMAlcon Lensx, Inc.·Product code OOE·2012-12-12
K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·Product code IYE·2012-12-12
K123352 — S4 SPINAL SYSTEMAesculap Implant Systems, Inc.·Product code NKB·2012-12-12
K113394 — MAVRIC SLGe Medical Systems, LLC·Product code LNH·2012-12-11
K113693 — NIXALL TM WOUND AND SKIN CARESeriously Clean, Ltd.·Product code FRO·2012-12-11
K120146 — QUARK SERIESCosmed Srl·Product code CBK·2012-12-11
K120237 — BPA-FREE MICROHYBID COMPOSITENovocol, Inc.·Product code EBF·2012-12-11
K120356 — NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MDNcs Lab Srl·Product code MBI·2012-12-11
K120791 — AMBIENT TURBOFLASH 90 IFSArthocare Corporation·Product code GEI·2012-12-11
K120866 — DA01 BLOOD GLUCOSE MONITORING SYSTEMDelbio Incorporation·Product code NBW·2012-12-11
K121266 — CARDIOSCOPEPulsecor Limited·Product code DXN·2012-12-11
K121620 — ULTRASONIC SURGERYDmetec.Co., Ltd.·Product code DZI·2012-12-11
K121843 — NP-CAST ABUTMENT SYSTEMOsstem Implant Co., Ltd.·Product code NHA·2012-12-11
K122158 — PBP TOTAL HIP SYSTEMPipeline Biomedical Products, LLC·Product code OQG·2012-12-11
K122268 — ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOSDentsply International·Product code NHA·2012-12-11
K122421 — TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUIDKuraray Noritake Dental, Inc.·Product code EJK·2012-12-11
K122892 — MTA2 ROOT AND PULP MATERIALSAvalon Biomed, Inc.·Product code KIF·2012-12-11
K122980 — GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQTerumo Medical Corporation·Product code DYB·2012-12-11
K123113 — L.A.M. IMP WOUND GELGlycobiosciences, Inc.·Product code FRO·2012-12-11
K123317 — EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190NOlympus Medical Systems Corporation·Product code FDS·2012-12-11
K123479 — PROGRIP LAPAROSCOPIC SELF-FIXATING MESHSofradim Production·Product code FTL·2012-12-11
K120282 — CARDNAVPaieon, Inc.·Product code OWB·2012-12-10
K120953 — PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEMTlelflex Medical, Inc.·Product code CAC·2012-12-10
K121391 — INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTSPrismatik Dentalcraft, Inc.·Product code NHA·2012-12-10
K122018 — OP300Palodex Group OY·Product code OAS·2012-12-10
K122489 — EMERGE MEDICAL SOLID BONE SCREWSEmerge Medical·Product code HWC·2012-12-10
K122740 — JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHINJetprep, Ltd.·Product code OCX·2012-12-10
K122828 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)Shandong Hongxin Chemicals Co., Ltd.·Product code LYZ·2012-12-10
K122835 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)Yuanhang Plastic Co., Ltd.·Product code LYZ·2012-12-10
K122874 — POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITENitrilist Gloves Manufacturing Sdn Bhd·Product code LZA·2012-12-10
K120454 — SAFEAIR SMOKE PENCIL,Lna Medical Aps·Product code GEI·2012-12-07
K120502 — PC-60NW FINGERTIP OXIMETERShenzhen Creative Industry Co., Ltd.·Product code DQA·2012-12-07
K120813 — BLOOD GLUCOSE MONITORING SYSTEMAndon Medical Co., Ltd.·Product code NBW·2012-12-07
K120932 — OPELASER PRO II AND THE OPELASER LITE IIThe Yoshida Dental Mfg. Co., Ltd.·Product code GEX·2012-12-07
K121495 — LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONGAap Implantate AG·Product code HRS·2012-12-07
K121703 — LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGEMedi-Khan USA, Inc.·Product code MUU·2012-12-07
K122105 — SMI CARDIOVASCULAR PATCHSolinas Medical, Inc.·Product code DXZ·2012-12-07
K122330 — FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILEArjohuntleigh Polska SP Z.O.O.·Product code JOW·2012-12-07
K122475 — ZQUIET PRO-PLUSSleeping Well, LLC·Product code LRK·2012-12-07
K122546 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEMIdev Technologies, Inc.·Product code FGE·2012-12-07
K122582 — DENTAL X-RAY Z70 (3 models)Denterprise International, Inc.·Product code EHD·2012-12-07
K122684 — REVERSE MEDICAL MICROCATHETERReverse Medical Corporation·Product code DQY·2012-12-07
K122733 — V2F ANTERIOR FIXATION SYSTEMZimmer Spine, Inc.·Product code KWQ·2012-12-07
K122742 — NUVASIVE BENDINI SPINAL ROD BENDING SYSTEMNuvasive, Inc.·Product code OLO·2012-12-07
K122760 — AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.·Product code DTM·2012-12-07
K122845 — ES2 SPINAL SYSTEM MODEL 48280XXXXStryker Spine·Product code NKB·2012-12-07
K122861 — XTOOLOuroboros Medical·Product code HRX·2012-12-07
K122953 — OMNIPOD INSULIN MANAGMENT SYSTEMInsulet Corporation·Product code LZG·2012-12-07
K123005 — DDRVERSA MOTIONSwissray Medical AG·Product code MQB·2012-12-07
K123152 — VITESSE 3.0Varian Medical Systems, Oncology Systems·Product code MUJ·2012-12-07
K123265 — RMGI LOW VISCOSITYPulpdent Corporation·Product code EMA·2012-12-07
K123273 — HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)Temrex Corp.·Product code EMA·2012-12-07
K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELFHeraeus Kulzer, LLC·Product code KLE·2012-12-07
K123446 — TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEMUnited States Gtm Medical Devices, Inc.·Product code DXN·2012-12-07
K123462 — OCELOT CATHETERAvinger, Inc.·Product code PDU·2012-12-07
K112079 — APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720Apex Medical Corp.·Product code BZD·2012-12-06
K120770 — QT GUARD PLUS ANALYSIS SYSTEMGe Medical Systems Information Technologies·Product code DPS·2012-12-06
K120858 — IMPLANT BARPrismatik Dentalcraft, Inc.·Product code NHA·2012-12-06
K121067 — EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATEExactech, Inc.·Product code PHX·2012-12-06
K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America·Product code KDI·2012-12-06
K121382 — WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]Westmed, Inc.·Product code CAH·2012-12-06
K121440 — ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITSiesta Medical, Inc.·Product code ORY·2012-12-06
K122034 — MRJ 3300Paramed S.R.L.·Product code LNH·2012-12-06
K122097 — PATRIOT SPACERSGlobus Medical, Inc.·Product code MAX·2012-12-06
K122101 — CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C CSebia·Product code LCP·2012-12-06
K122322 — PIEZOSURGERY TOUCHMectron S.P.A.·Product code DZI·2012-12-06
K122432 — ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITSFisher & Paykel Healthcare, Ltd.·Product code BZE·2012-12-06
K122787 — COMFORT EZSimple Diagnostics, Inc.·Product code FMF·2012-12-06
K122852 — PHYSIOSTAR NFCCandulor USA, Inc.·Product code ELM·2012-12-06
K121640 — ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEMMaterialise NV·Product code JWH·2012-12-05
K121663 — CLARITYElekta , Ltd.·Product code IYE·2012-12-05
K122088 — MERIT ONE SNARE SYSTEMMerit Medical Systems, Inc.·Product code MMX·2012-12-05
K122242 — ELECSYS CA 15-3 II CALCHECK 5Roche Diagnostics·Product code JJX·2012-12-05
K122248 — IGROW II HAIR GROWTH SYSTEMApira Science, Inc.·Product code OAP·2012-12-05
K122605 — PKS BILLGyrus Acmi, Inc.·Product code HIN·2012-12-05
K122630 — IN:C2 SPINAL FIXATION SYSTEMSpine Smith Partners L.P.·Product code OVE·2012-12-05
K122645 — MOBILE CAREGUIDE 2100 OXIMETERReflectance Medical, Inc.·Product code MUD·2012-12-05
K122745 — ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMZimmer, Inc.·Product code MBH·2012-12-05
K122759 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)Omega Laboratories, Inc.·Product code LDJ·2012-12-05
K123137 — CALYPSO SYSTEMVarian Medical Systems·Product code IYE·2012-12-05
K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)Nanosphere, Inc.·Product code OZN·2012-12-05
K123226 — LESSRAYSaferay Spine, LLC·Product code OWB·2012-12-05
K123622 — ACUSONSiemens Medical Solutions USA, Inc.·Product code IYN·2012-12-05
K120995 — ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCTErad, Inc.·Product code LLZ·2012-12-03
K122660 — RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612Boston Scientific Corporation·Product code PKL·2012-12-03
K122692 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMSZimmer, Inc.·Product code PHX·2012-12-03
K122814 — GALLEON PEDICLE SCREW SYSTEMEverest Spine, LLC·Product code MNH·2012-12-03
K122829 — LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONSLensar, Inc.·Product code HQC·2012-12-03
K122901 — FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEMOrthofix·Product code NKB·2012-12-03
K123031 — BWF-5 MEDICAL LASER SERIESLitecure, LLC·Product code GEX·2012-12-03
K123451 — POLARIS SPINAL SYSTEM - BALLISTA II RODSBiomet Spine (Aka Ebi, LLC)·Product code NKB·2012-12-03
K123463 — INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALSIntuitive Surgical, Inc.·Product code NAY·2012-12-03
K103542 — GENSTRIP TEST STRIP MODEL 100-201Shasta Technologies, LLC·Product code NBW·2012-11-30
K121321 — HARD SHELL VENTED NASAL MASKSleepnet Corporation·Product code BZD·2012-11-30
K121361 — CURALINE POLYURETHANE FOAM AWC DRESSINGCuraline, Inc.·Product code FRO·2012-11-30
K121559 — HYLATOPICPLUS LOTIONPrecision Dermatology Incorporated·Product code FRO·2012-11-30
K121936 — NAVIOPFSBlue Belt Technologies, Inc.·Product code OLO·2012-11-30
K121994 — DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATORSiemens Healthcare Diagnostics, Inc.·Product code CDD·2012-11-30
K122326 — SMARTTOOLS KNEE SYSTEMZimmer·Product code OLO·2012-11-30
K122419 — UCP HOME DRUG SCREENING TEST CUPSUcp Biosciences, Inc.·Product code DKZ·2012-11-30

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