FDA 510(k) clearances — page 499
clearances on record, most recent first.
Clearances — page 499
49,801–49,900 of 176,542- K102655 — POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE)
- K102844 — ALL-BOUND 3
- K102905 — GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)
- K102906 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K103050 — DX-D 300
- K100244 — METRO SOFT
- K100443 — DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
- K100456 — CVUE ADVANCED DEFINITIVE
- K100574 — COLLEXA
- K101123 — NEXFIN MODEL 2
- K101545 — GENESIS IMPLANT SYSTEM
- K102138 — ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
- K092333 — PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
- K100499 — ORGENTEC RHEUMATOID FACTOR EIA
- K101712 — ENDOVASCULAR LAER VEIN SYSTEM KIT
- K101935 — CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
- K102538 — ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI
- K102545 — FM-02 BONE GRAFT SUBSTITUTE
- K102901 — HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER
- K091393 — ELEKTA NEUROMAG WITH MAXFILTER
- K100489 — DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
- K101355 — AUGEASE VASCULAR AUGMENTATION DEVICE
- K101571 — XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
- K101718 — OSSEOCONDUCT
- K101756 — TSC
- K101951 — LIGHT CURE RETAINER
- K102110 — 24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN
- K102420 — EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
- K102523 — MULTI-LEAD TRIALING CABLE MODEL 355531
- K102758 — TRULIGHT 5520 AND TRULIGHT 5320
- K102801 — PHTIP DISPOSABLE ISFET CATHETER
- K103010 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT
- K103121 — ECO-S
- K101235 — CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
- K101683 — INFINITI CYP2C19 ASSAY
- K093069 — NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
- K093293 — VANGUARD 360 REVISION KNEE SYSTEM
- K100152 — SIRONA CAD/CAM SYSTEM
- K100212 — DENTACENTER/EXPEDITION, MODEL SAF-430
- K100248 — DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
- K100660 — INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000
- K100744 — CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140
- K100944 — CLAVICLE LOCKING PLATE SYSTEM
- K101525 — PIONEER SPINOUS PROCESS FUSION PLATE
- K101679 — ARTHREX PUSHLOCK ANCHORS
- K101759 — QUANTUM RING FIXATION SYSTEM MODEL ISF
- K101765 — KYPHON ANCHOR FACET SCREW SYSTEM
- K101839 — KANEKA PHARMA AMERICA XPRESS-WAY RX
- K101921 — VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
- K102003 — XPRESS BALLOON DEVICE
- K102124 — DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K102135 — VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM
- K102168 — SENSEI X ROBOTIC CATHETER SYSTEM
- K102526 — BLO2X OXYGEN BLOCKER
- K102680 — Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
- K102991 — M5 DIAGNOSTIC ULTRASOUND SYSTEM
- K103095 — SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
- K092641 — CHARMCARE TABLETOP PULSE OXIMETER
- K093076 — VITEK 2 GRAM POSITIVE DOXCYCLINE
- K100172 — TOKUYAMA SHIELD FORCE
- K100742 — EXACTECH GPS
- K100960 — WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS
- K100976 — T2 XVBR 1.5 SPINAL SYSTEM
- K101006 — WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
- K101014 — BOND BONE
- K101104 — REMIN PRO
- K101145 — SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
- K101847 — URGENT PC STIMULATOR; URGENT PC LEAD SET
- K101896 — MASIMO LNCS/M-LNCS OXIMETRY SENSORS
- K102262 — ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP; EXTRACTION TOOL
- K102559 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K102562 — INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
- K102569 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K102570 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
- K102611 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102890 — K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)
- K092256 — THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
- K092571 — GYRUS ACMI BIOCOAG PROBE
- K101309 — EXELINT ALUMINUM HUB BLUNT NEEDLES
- K101497 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
- K101843 — DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
- K101936 — CONTOURS VSP III VOLAR PLATING SYSTEM
- K102031 — GALAXY LITE
- K102088 — JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT
- K102131 — NANO-CHECK AMI CTNI CARDIAC MARKER TEST
- K102426 — CARESCAPE MODEL V100 VITAL SIGNS MONITOR
- K102441 — NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
- K102443 — INTRAFIX TIBIAL SHEATH
- K102701 — VIPER SPINE SYSTEM
- K102903 — PIONEER CANNULATED SCREW SYSTEM
- K102916 — G-CATH TISSUE ANCHOR DELIVERY CATHETER
- K092809 — HRV ACQUIRE
- K093244 — UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX
- K093803 — BIO-MODULAR REVERSE SHOLDER
- K101417 — BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
- K102023 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
- K102732 — VASOGRAD DVT COMPRESSION GARMENT
- K102737 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
- K093105 — VISTEO
- K093471 — KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.