FDA 510(k) clearances — page 520

176,542 clearances on record, most recent first.

Clearances — page 520

51,901–52,000 of 176,542

K093331 — SR PHONARES NHCIvoclar Vivadent, Inc.·Product code ELM·2010-01-28
K093386 — CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FSTBfw, Inc.·Product code FST·2010-01-28
K093433 — VARIAX ELBOW SYSTEM PLATE LINE EXTENSIONHowmedica Osteonics Corp.·Product code HRS·2010-01-28
K093560 — UPCERA ZIRCONIA BLANKSShenyang Upcera Co., Ltd.·Product code EIH·2010-01-28
K093667 — SHOULDER SPEEDER COILQuality Electrodynamics·Product code MOS·2010-01-28
K093822 — DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILYShepherd Scientific, Inc.·Product code DQX·2010-01-28
K100067 — MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEMToshiba America Medical Systems, In.C·Product code ITX·2010-01-28
K091428 — EASYONE PRO RESPIRATORY ANALYSIS SYSTEMNdd Medizitechnik AG·Product code BTY·2010-01-27
K092540 — C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACERRsb Spine, LLC·Product code ODP·2010-01-27
K092846 — AIRVO SERIES HUMIDIFIERSFisher & Paykel Healthcare, Ltd.·Product code BTT·2010-01-27
K093125 — ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbH·Product code GCT·2010-01-27
K093182 — SET GRI-FILL 3.0Laboratorios Grifols, S.A.·Product code LHI·2010-01-27
K093271 — EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARDVictus, Inc.·Product code FPA·2010-01-27
K093368 — BUTTERFLY TONER MODEL GYM070Global Marketing Partners Dba Gymmax USA·Product code NGX·2010-01-27
K093484 — PREMISE FLOWABLE MODIFIEDKerr Corporation·Product code EBF·2010-01-27
K093995 — IG 4 IMAGE GUIDED SYSTEMVeran Medical Technologies, Inc.·Product code JAK·2010-01-27
K091949 — MICROSCAN MICROSTREP PLUS, MODEL B1027-201Siemens Healthcare Diagnostics·Product code LTT·2010-01-26
K092257 — JALOSKINFidia Advanced Biopolymers Srl·Product code FRO·2010-01-26
K092845 — RESPISENSNomics·Product code IYE·2010-01-26
K093070 — DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIESSunrise Medical·Product code MNS·2010-01-26
K093363 — COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERSSmith & Nephew, Inc.·Product code MBL·2010-01-26
K093681 — MERIDIAN GUIDEWIREEv3 Neurovascular·Product code DQX·2010-01-26
K100076 — ATRIUM C-QUR OVT MESHAtrium Medical Corp.·Product code FTL·2010-01-26
K091717 — ANY PLUS SPINAL FIXATION SYSTEMGS Medical Co., Ltd.·Product code NKB·2010-01-25
K092106 — U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132Taidoc Technology Corporation·Product code DXN·2010-01-25
K092224 — TIGR SURGICAL MESH , MODEL WK-6Novus Scientific Pte, Ltd.·Product code FTL·2010-01-25
K093364 — SOLO MICROPUMP INSULIN DELIVERY SYSTEMMedingo , Ltd.·Product code LZG·2010-01-25
K093464 — RAPIDSORB PLUS SCREW SYSTEMSynthes (Usa)·Product code DZL·2010-01-25
K094020 — GRIND NO MORE GENERATION IIRanir, LLC·Product code OBR·2010-01-25
K094036 — TURBO-TANDEM SYSTEM MODEL 472-110Spectranetics Corp.·Product code MCW·2010-01-25
K091328 — SIPHONX GRAVITATIONAL ANTISIPHON DEVICESophysa SA·Product code JXG·2010-01-22
K091387 — BTI DENTAL IMPLANT 5.5-6.5B.T.I. Biotechnology Institute, Sl.·Product code DZE·2010-01-22
K092098 — PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESISSmith & Nephew, Inc.·Product code LPH·2010-01-22
K092360 — ACP4 SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.·Product code KWQ·2010-01-22
K092684 — LAPAROSCOPIC RETRACTORSCardinal Health, Inc.·Product code GCJ·2010-01-22
K092818 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEMRespironics, Inc.·Product code MNS·2010-01-22
K093080 — METAPHOR METABOLIC MONITORTreymed, Inc.·Product code BZL·2010-01-22
K093162 — FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FIDFotona D.D.·Product code GEX·2010-01-22
K093185 — OWL UNIVERSAL RF SYSTEM URF-3AP (ML)Diros Technology, Inc.·Product code GXD·2010-01-22
K093781 — MODIFIED: NEWDEAL HALLU PLATESNewdeal Sas·Product code HRS·2010-01-22
K093823 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JMHealth & Life Co., Ltd.·Product code DXN·2010-01-22
K093950 — BIOFOAM BONE WEDGE MODEL ASSORTEDWrightmedicaltechnologyinc·Product code HRS·2010-01-22
K093968 — OSV II LOW FLOW LOW PRO VALVEIntegra LifeSciences Corporation·Product code JXG·2010-01-22
K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLENipro Medical Corp.·Product code FIE·2010-01-22
K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERSSorin Group Italia S.R.L.·Product code DTM·2010-01-22
K090953 — TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCKPraxim Medivision, SA·Product code OLO·2010-01-21
K091425 — QUANTUM M COMPOSITE NAILING SYSTEMN.M.B. Medical Applications, Ltd.·Product code HSB·2010-01-21
K091863 — AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUSAubrey, Inc.·Product code FRO·2010-01-21
K092096 — ENDOFORM DERMAL TEMPLATEMesynthes, Ltd.·Product code KGN·2010-01-21
K092124 — AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF IITrans1 Incorporated·Product code KWQ·2010-01-21
K092250 — MEDLINE RED RUBBER URETHRAL CATHETERMedline Industries, Inc.·Product code EYB·2010-01-21
K092263 — ENDURAVENT-5 VENTILATORProvidence Global Medical, Inc.·Product code CBK·2010-01-21
K092388 — DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MOIntegra LifeSciences Corporation·Product code GXQ·2010-01-21
K093075 — ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENTAragon Surgical, Inc.·Product code GEI·2010-01-21
K093092 — ODYSSEY WORKSTATIONStereotaxis, Inc.·Product code DQK·2010-01-21
K093195 — ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-OCook Ireland, Ltd.·Product code FCG·2010-01-21
K093217 — 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)Intuitive Surgical, Inc.·Product code NAY·2010-01-21
K093370 — FU HONG INDUSTRIES LIMITED SOOTHER TEETHERFu Hong Industries , Ltd.·Product code KKO·2010-01-21
K093427 — FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTORFujifilm Medical System U.S.A., Inc.·Product code MQB·2010-01-21
K093587 — DENTAL MERCURYDmg USA, Inc.·Product code ELY·2010-01-21
K093911 — FOGARTY OCCLUSION CATHETEREdwards Lifesciences, LLC·Product code MJN·2010-01-21
K093918 — JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)Pathway Medical Technologies, Inc.·Product code MCW·2010-01-21
K093919 — MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.·Product code HCG·2010-01-21
K093944 — MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA SMedacta International S.A.·Product code LZO·2010-01-21
K093947 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPICMerit Medical Systems, Inc.·Product code FGE·2010-01-21
K093972 — BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706Becton, Dickinson & CO·Product code JKA·2010-01-21
K082805 — PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXXQ Urological Corporation·Product code FAD·2010-01-20
K092110 — WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)Sonoma Orthopedic Products, Inc.·Product code HSB·2010-01-20
K093022 — THE PICC WAND PEELABLE SAFETY INTRODUCERAccess Scientific, Inc.·Product code DYB·2010-01-20
K093065 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000Calibra Medical, Inc.·Product code OPP·2010-01-20
K093172 — QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)Dynacardia, Inc.·Product code DPS·2010-01-20
K093593 — CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PROMedtrade Products Limited·Product code QSY·2010-01-20
K091765 — EBCARRYON BLOOD GLUCOSE MONITORING SYSTEMVisgeneer, Inc.·Product code NBW·2010-01-19
K091936 — BLADE ANTERIOR CERVICAL PLATE SYSTEMNexxt Medical, Inc.·Product code KWQ·2010-01-19
K092655 — C. ALBICANS PNA FISHAdvandx, Inc.·Product code NZS·2010-01-19
K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061Small Bone Innovations, Inc.·Product code HWC·2010-01-19
K092978 — IMMUNOCAP RAPID READER, MODEL 12-3600-10Phadia US, Inc.·Product code DHB·2010-01-19
K093200 — LIFE SPINE LUMBAR PLATE SYSTEMLife Spine·Product code KWQ·2010-01-19
K093445 — KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)Keeler, Ltd.·Product code HKY·2010-01-19
K093500 — POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILEWear Safe (Malaysia) Sdn. Bhd.·Product code LZC·2010-01-19
K093693 — NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PHNoras Mri Products GmbH·Product code MOS·2010-01-19
K093703 — 3DIShina Systems , Ltd.·Product code LLZ·2010-01-19
K093713 — ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEMCivco Medical Instruments·Product code ITX·2010-01-19
K093849 — ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEMMedison Co., Ltd.·Product code IYN·2010-01-19
K093923 — CEROX MODEL 3210Or-Nim Medical , Ltd.·Product code MUD·2010-01-19
K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMAbaxis, Inc.·Product code DCN·2010-01-15
K091259 — ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPSEthicon Endo-Surgery, Inc.·Product code GEI·2010-01-15
K091511 — MODERN MEDICAL RESECTOSCOPE ELECTRODESModern Medical Equipment Mfg., Ltd.·Product code FAS·2010-01-15
K091547 — NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSNova Biomedical Corp.·Product code NBW·2010-01-15
K091674 — ARTHROCARE COBLATOR IQ SYSTEMArthrocare Corp.·Product code GEI·2010-01-15
K091950 — SMART-WELL EZTEST INCUBATORSgm Biotech, Inc.·Product code FRC·2010-01-15
K092743 — THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEMStryker Craniomaxillofacial·Product code JEY·2010-01-15
K092878 — PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBEPrugen IP Holdings, Inc.·Product code FRO·2010-01-15
K093223 — COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECGCompumedics Limited·Product code GWQ·2010-01-15
K093358 — MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.·Product code HCG·2010-01-15
K093657 — ADAGIO RETRACTING ECG LEAD WIRESAcist Medical Systems, Inc.·Product code DSA·2010-01-15
K093855 — HALO 360 & SIZING BALLOON, MODEL 3441CBarrx Medical, Incorporated·Product code GEI·2010-01-15
K093882 — SORIN C5 SYSTEM MODEL 58-00-00Sorin Group Deutschland GmbH·Product code DTQ·2010-01-15
K093970 — PICA CATHETERPenumbra, Inc.·Product code LIT·2010-01-15
K082275 — CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023Infopia Co, Ltd.·Product code LCP·2010-01-14

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