FDA 510(k) clearances — page 490
clearances on record, most recent first.
Clearances — page 490
48,901–49,000 of 176,542- K110093 — SUPERDIMENSION MARKER DELIVERY KIT
- K110103 — EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
- K110134 — NC TREK RX CORONARY DILATATION CATHETER
- K110157 — SYSLOC MINI V3
- K092202 — ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
- K093661 — COLONRING
- K101270 — SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
- K101873 — MASTERSCREEN IOS
- K102283 — ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
- K102738 — LANX FUSION SYSTEM
- K103101 — HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
- K103137 — VENUS ANTERIOR CERVICAL PLATE
- K103242 — REDSENSE-ALARM UNIT AND SENSOR
- K103540 — PSORIA-LIGHT
- K103553 — LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
- K103564 — VENOFER PUMP
- K110049 — REUSABLE LINEAR STAPLER HANDLE
- K110079 — SPPHINE PLUS STM 3W DIODE LASER
- K100225 — PULSE OXIMETER MODEL P10
- K100945 — FUSE PLIF CAFE
- K101979 — EXPLORER LIVER (PASSIVE TRACKING)
- K102296 — VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)
- K103085 — VENUS BASIC SPINAL FIXATION SYSTEM
- K103145 — HAMMERLOC TM TIBIAL FIXATION DEVICE
- K103310 — CRYONIZE TM
- K110010 — NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
- K110205 — AAIO-7, AAIO WIRLESS
- K100533 — VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
- K101236 — VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
- K101902 — J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
- K101988 — HEAL FORCE CO2 INCUBATOR
- K103040 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
- K103102 — LEUCADIA PEDICLE SCREW SYSTEM
- K103183 — TRILLIANT SURGICAL SUBTALAR IMPLANT
- K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
- K103195 — I-STAT 1 WIRELESS ANALYZER
- K103276 — INTEL HEALTH GUIDE
- K103316 — FLOWREST
- K103507 — MEDICAL VISORS MV100
- K103781 — MED-LOK SAFETY NEEDLE
- K110069 — SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
- K110192 — DEFIBRILLATOR ANALYZER - DA-2006P
- K110199 — DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
- K110202 — FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
- K082254 — MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
- K082255 — QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
- K101439 — CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
- K101900 — HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
- K102470 — LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
- K102547 — COROENT INTERLOCK SYSTEM
- K103054 — PERIOPATCH
- K103158 — STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
- K103173 — VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
- K103192 — NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
- K103373 — SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
- K103474 — ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
- K103787 — MEDEOR MATRIX
- K110164 — 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
- K093835 — BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
- K100371 — SPY INTRA-OPERATIVE IMAGING SYSTEM
- K101077 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
- K101312 — NUVUE COLORMARK9TM) NEEDLE
- K101353 — GOLDEN GATE ANTERIOR PLATE SYSTEM
- K101392 — NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
- K101398 — STEREOS WORKSTATION
- K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
- K101743 — 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319
- K101842 — ACIES
- K101969 — MH1 MICROHOLTER RECORDER
- K102753 — TURBO TEMP 3
- K103403 — MULTICONSTITUENT CALIBRATOR
- K103516 — AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
- K103707 — VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
- K103732 — SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
- K103785 — MOBILE MIM
- K103816 — COHESION BONE CEMENT
- K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
- K110124 — FETAL DOPPLER JPD-100S
- K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
- K101801 — MONICA AN24
- K101890 — BALL ABUTMENT SYSTEM
- K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE
- K102592 — SUTRAZORB
- K102652 — NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
- K102838 — PATIENT EXAMINATION GLOVES
- K102892 — ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
- K103020 — ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
- K103233 — MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
- K103309 — OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
- K103561 — MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- K110045 — INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
- K100927 — SURGIAID
- K100948 — HYPO CLENZ WOUND WASH MODEL 100 PPM
- K102742 — NASAL CEASE
- K102795 — SIGNATURE PLANNER; SIGNATURE GUIDES
- K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL
- K102995 — TALON SPINAL SYSTEM
- K103011 — ULTICARE SAFETY INSULIN SYRINGE
- K103113 — VASCULAIRE COMPRESSION SYSTEM
- K103143 — ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.