FDA 510(k) clearances — page 491
clearances on record, most recent first.
Clearances — page 491
49,001–49,100 of 175,770- K102930 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K102994 — K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
- K102074 — POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
- K102351 — GRANDIO SO
- K102583 — MUCHECK, VERSION 9.0
- K092273 — RANDOX ETHANOL ASSAY
- K102086 — ELECSYS CA 125 II CALCHECK 5
- K102983 — VASCUCLEAR PRECISION BIPOLAR
- K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
- K092477 — NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
- K092896 — REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
- K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
- K100926 — ARROWHEAD FIXATION DEVICE
- K101035 — WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
- K101042 — BLADEVIEW
- K101305 — ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
- K101437 — SPEEDFIX SUTURE SYSTEM
- K101504 — TI-CORE FLOW
- K101540 — GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
- K101686 — FDR IMAGE STITCHING OPTION
- K101707 — FULACCESS MODEL 1.0
- K101917 — COMFORT RUBBER GLOVES IND.SDN.BHD.
- K101961 — TIGERPAW SYSTEM
- K102013 — DIGITAL RETINAL CAMERA
- K102314 — 3M INTEGRATED CYCLER (110V) & (220V)
- K102347 — GRANDTEC
- K102423 — DEPUY PINNACLE ALTRX ACETABULAR LINERS
- K102575 — ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.