FDA 510(k) clearances — page 402
clearances on record, most recent first.
Clearances — page 402
40,101–40,200 of 175,770- K131830 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K131977 — CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
- K131988 — ABL90 FLEX ANALYZER
- K132164 — HEARTSPAN STEERABLE INTRODUCER KIT
- K132590 — 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
- K132591 — MAXLOCK EXTREME SYSTEM
- K132593 — CRYSTALSERT DELIVERY SYSTEM
- K123957 — PNEUPAC PARAPAC PLUS
- K123991 — DEPUY CORAIL AMT HIP PROSTHESIS
- K130760 — ELECTROSURGICAL GENERATOR
- K130802 — OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
- K130996 — ERCHONIA EMERGE
- K131398 — NOVOKNEE TOTAL KNEE SYSTEM
- K131494 — HEART SYNC
- K132053 — RAMPART-O, RAMPART-T
- DEN130023 — UROLIFT SYSTEM
- K123866 — TANYX
- K123902 — PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
- K124026 — LOBSTER AUTO-INJECTOR
- K124031 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
- K130641 — LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
- K130873 — VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
- K131059 — PIONEER ELITE DIODE LASER
- K131084 — SASMAR ORIGINAL, SASMAR CLASSIC
- K131409 — CAS PSI KNEE SYSTEM
- K131508 — VYSIS D7S486/CEP 7 FISH PROBE KIT
- K131854 — CEROX
- K132175 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
- K132249 — ADVIA CENTAUR FT4, ADVIA CENTAUR T4
- K132573 — VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
- K132578 — INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
- K112796 — SURGICAL GOWN (EO STERILIZED)
- K124037 — JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
- K130417 — AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
- K130604 — UNIVERSAL PASTE STAINS AND GLAZE
- K130703 — VIVORTE BVF
- K130925 — AUTOMATIC BLOOD PRESSURE MONITOR
- K131578 — IPROPHY MOBILE
- K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
- K132137 — MULTISTIM
- K132198 — ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
- K132302 — QXLINK
- K132505 — ACCULIF TL AND PL CAGE
- K130841 — SHOFU BLOCK HC
- K131021 — PULSE OXIMETER
- K131111 — IHEALTH FINGERTIP PULSE OXIMETER
- K131208 — BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
- K131491 — KITAZATO IUI CATHETER
- K131565 — XTAG CYP2C19 KIT V3
- K123567 — FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
- K123896 — CCS-200 SPIROMETER
- K131043 — APEX UNIVERSAL ADHESIVE
- K131250 — TIGER SPINE SYSTEM
- K132005 — RETROGRADE FEMORAL NAIL
- K122102 — POWER FREE VINYL EXAMINATION GLOVES
- K123630 — FRESENIUS LIBERTY CYCLER
- K131138 — RESPIRE PINK SERIES - HERBST
- K132073 — EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
- K132216 — BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
- K132465 — BIOSIGN FLU A + B, STATUS FLU A & B
- K121033 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
- K121844 — POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
- K122235 — RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
- K130010 — PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
- K130341 — STRAWBERRY, STRAWBERRY & CREAM
- K130349 — FREEMIE BREAST COLLECTION SYSTEM
- K130409 — ALIVECOR HEART MONITOR
- K130893 — XPERCT REL. 3
- K131037 — LIAISON XL HCG
- K131357 — PEAK Z
- K131389 — JUSHA-C31 MEDICAL DISPLAY
- K131442 — FIRECR DENTALIMAGING SYSTEM
- K131658 — GORE SEAMGUARD REINFORCEMENT
- K131681 — EYESEECAM VHIT
- K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAY
- K132136 — SINGLE USE GROUNDING PAD
- K132233 — K-PACK II NEEDLE - 27G X 3/4 THIN WALL
- K132239 — COMPREHENSIVE REVERSE SHOULDER SCREWS
- K132324 — SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
- K132431 — THERMAGE CPT SYSTEM
- K123723 — SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
- K123811 — STITCHKIT
- K123944 — KOSTEC MEDICAL GRADE LDC MONITORS
- K131311 — ARIX FOOT SYSTEM
- K131452 — PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
- K131701 — Z5MLB, Z5MLC
- K131764 — ACUMED WRIST SPANNING PLATE
- K132348 — TEPHAFLEX BRAIDED SUTURE
- K132492 — LIAISON 25 TOTAL-D
- K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM
- K131044 — SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
- K131064 — BIOSPACE
- K131148 — THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
- K131615 — POLARIS SPINAL SYSTEM
- K131980 — SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
- K132045 — ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
- K132610 — 5MP GRAYSCALE LCD DISPLAY
- K123907 — PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
- K130028 — RESURFX 1565NM LASER MODULE
- K131242 — ARDIS INTERBODY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.