FDA 510(k) clearances — page 485
clearances on record, most recent first.
Clearances — page 485
48,401–48,500 of 175,770- K103232 — CASPIAN SPINAL SYSTEM
- K103652 — SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
- K101904 — SMARTXIDE 50 HS/MS
- K102121 — ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
- K102338 — BREATHSCN PRO
- K102506 — MIXED MEDIA MARKER
- K102651 — ISCREEN VISION SCREENER
- K102834 — ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
- K102872 — OSBONE DENTAL
- K102915 — VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
- K103070 — GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
- K103144 — DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
- K103365 — DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
- K103394 — BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
- K103645 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
- K110030 — EXPECT ENDOSCOPIC ASPIRATION NEEDLE
- K092183 — EMBRYOSCOPE AND EMBRYOSLIDE
- K101535 — BT-CATH
- K101716 — HVR PAIN RELIEF DEVICE
- K101995 — CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
- K102781 — RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
- K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100
- K103275 — SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
- K103470 — PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP
- K102508 — YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02
- K102617 — AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
- K102822 — IMPLANT-ONE SYSTEM
- K103033 — TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
- K103036 — ALLOFUSE PLUS
- K103046 — HOSMAN USB BLOOD PRESSURE MONITOR; WRIST TYPE AND UPPER ARM TYPE
- K103064 — AVAMAX VERTEBRAL BALLOON
- K103110 — MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
- K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
- K103252 — CAMLOG VARIO SR ABUTMENTS
- K093280 — OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
- K101371 — ON CALL PLUS DIABETES MONITORING SOFTWARE
- K101588 — ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
- K101750 — RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104
- K101823 — ARTHREX SWIVELOCK ANCHORS
- K101953 — SMDIA-1000
- K102184 — MEDPOR CONTAIN CAN IMPLANT
- K102298 — TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
- K102304 — BREEZE C MODEL C (3W), BREEZE C (4W)
- K102322 — STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
- K102380 — EVOLUTION MP TOTAL KNEE SYSTEM
- K102823 — DISPOSABLE BLOOD PRESSURE CUFF
- K103043 — COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH
- K103117 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
- K103152 — 6250 ULTRASOUND SYTEMS
- K103224 — HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
- K103349 — BACKSTOP CATHETER
- K103402 — ELECSYS DHEA-S CALCHECK 5
- K103512 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
- K103646 — INTELLIVUE MX40 PATIENT MONITOR
- K100358 — CENTRAL MONITORING SYSTEM
- K100577 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
- K101024 — KENZ CARDY302 MAX
- K101616 — THE GRAPPLR AND GRAPPLR EXTENDER
- K102520 — BD NEXIVA CLOSED IV CATHETER SYSTEM
- K102649 — NEOPOP INFANT RESUSCITATOR WITH FLOW METER
- K102683 — THE ADDITION
- K103160 — NUPRO MODEL 13016901
- K103168 — B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
- K103610 — CLEARVIEW EXACT II INFLUENZA A & B TEST
- K100613 — BIOMED WOUND CLEANSER
- K101472 — MULTIFIT TOTAL HIP SYSTEM
- K101693 — GAUNYING INFRARED LAMP MODEL IL50
- K102293 — CALIBER SPACER
- K102379 — LTF-Y0009; MAJ-YOO41; XOEV-3D1
- K102513 — S9 VPAP ST WITH H5I
- K102544 — SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
- K102698 — PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE
- K102703 — BUILD-IT TOTAL CORE
- K102806 — NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
- K102982 — ENDOBUTTON DIRECT
- K103047 — CERETENE SOLUBLE IMPLANT MATERIAL
- K103060 — ARTHREX TIBIAL GRAFTBOLT
- K103228 — PARAMOUNT R IBF DEVICE
- K103287 — SYNTHES 6.0 COCR AND CPT TI-3 RODS
- K103475 — SPINEANALYER MODEL SAPOC
- K103534 — GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
- K103618 — TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
- K103722 — THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
- K093595 — CERAROOT IMPLANT SYSTEM
- K101350 — RADSCAN EQUIPMENT SLICKER
- K102226 — DUAL INCU I
- K102974 — INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
- K102998 — CONGRUENT BONE PLATE SYSTEM
- K103550 — YOBOSHI DENTAL UNIT
- K101853 — PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
- K102284 — KRYSTALRAD 560 (FLAATZ 560)
- K102285 — KRYSTALRAD (ATAL8)
- K103073 — SUPER CHAIR FOR KIDS BY ORION
- K103149 — 1.5T 16-CHANNEL HAND-WRIST COIL
- K103212 — ROUGHRIDER
- K103319 — I-SEED
- K103415 — TANDA MAX
- K103433 — F20
- K103597 — DX-D 100
- K090105 — LUPOTEK KCT
Data sourced from openFDA. This site is unofficial and independent of the FDA.