FDA 510(k) clearances — page 664
clearances on record, most recent first.
Clearances — page 664
66,301–66,400 of 176,637- K050738 — FT FIBER OPTIC DELIVERY SYSTEMS
- K051036 — HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
- K040290 — DIASORIN LIAISON CMV IGM/IGG
- K040871 — FACEMASTER FACIAL TONING SYSTEM
- K041897 — MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01
- K042297 — ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
- K042644 — AESKULISA TTG A AND AESKULISA TTG G
- K043377 — ZENO
- K050568 — ORLUS MINI SCREW
- K050721 — ABX ERYTROL
- K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY
- K050925 — DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
- K050947 — MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
- K051022 — GAMMAPLAN
- K051107 — ONYX II FINGER PULSE OXIMETER, MODEL 9550
- K051133 — ARCADIS AVANTIC
- K051167 — REVOLIX AND REVOLIX JR
- K051258 — KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
- K051308 — MYLAB 70 ULTRASOUND IMAGING SYSTEM
- K043067 — ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
- K043442 — STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
- K050638 — LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
- K050856 — LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
- K051086 — SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
- K051116 — MODEL TL-560 POWER SCOOTER
- K051118 — MODEL TL-360 POWER SCOOTER
- K033262 — MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
- K042431 — PROCON2
- K042606 — MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
- K043198 — VANGUARD REPROCESSED ARTHROSCOPIC WANDS
- K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
- K050006 — BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO
- K050065 — FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
- K050146 — VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
- K050251 — BALANCE HIP SYSTEM
- K050259 — ARTHREX BIO-PIN
- K050332 — SURGI-WRAP MAST BIORESORBABLE SHEET
- K050348 — CO VERTEBRAL BODY REPLACEMENT
- K050453 — ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
- K050454 — OMNITECH FULGURATING ELECTRODE
- K050557 — AMT NANOCATH
- K050658 — RESO-PAC PERIODONTAL DRESSING
- K050789 — FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
- K050861 — PEEK CAS
- K050868 — MAXLOCK
- K050882 — NEWDEAL ANKLE NAIL
- K050924 — MERETE DUOTHREADTM BONE SCREW
- K050946 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML
- K051067 — PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
- K051075 — ENCORE REVERSE SHOULDER PROSTHESIS
- K051173 — SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
- K051213 — PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
- K051252 — MICROPUMP MP-101
- K051341 — INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059
- K050166 — PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
- K050185 — POWERHOHN AND POWERLINE CATHETERS
- K050261 — V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
- K050632 — ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
- K050669 — JEIL BONE FIXATION SYSTEM
- K050693 — ACCENT
- K050718 — DDRCOMBI TRAUMA
- K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
- K050846 — B-CAD SYSTEM, VERSION 1.0
- K050850 — XPAND CORPECTOMY SPACER
- K050873 — CANALIZER HYDROPHILIC GUIDE WIRE
- K050875 — U-BALLOON DILATION CATHETER
- K050980 — ULTRASONIC BIO-MICROSCOPE, MODEL P60
- K050993 — MMS VIDEO OPTION
- K051060 — ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
- K051064 — ZIEHM QUANTUM
- K051065 — RAYCELL X-RAY BLOOD IRRADIATOR
- K051201 — E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY
- K043149 — FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)
- K043234 — LIGHT DRAPE
- K043249 — ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
- K050248 — ELECTRODE
- K050389 — ULTRA-SOFT SV BALLOON DILATATION CATHETER
- K050610 — SALUTE FIXATION SYSTEM
- K050898 — SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
- K050904 — CPAP HUMIDIFIER, MODEL HC238JHU
- K051092 — DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
- K051203 — BLUELEX
- K050897 — NAVIPRO SHOULDER SOFTWARE MODULE
- K050982 — BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)
- K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- K043592 — REPROCESSED ENDOSCOPIC TROCAR
- K050098 — DDAT OMT
- K050305 — ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
- K050595 — FT2000 SEQUENCER FOR MUSCLE STIMULATOR
- K050735 — MC6A
- K050888 — INTEGRA IMMOBILIZATION SYSTEM
- K050943 — GE VIEWPOINT
- K050976 — VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
- K051032 — TITANIUM-HIP TOOL
- K051055 — INTRABEAM SYSTEM
- K051063 — POLYAXIAL HEMISPHERICAL SPINAL SCREWS
- K051170 — GEMINI GXL
- K051181 — CUSTOM-HIP TOOL
- K041971 — WIMRT MODULE FOR ARTP PLANNING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.