FDA 510(k) clearances — page 482
clearances on record, most recent first.
Clearances — page 482
48,101–48,200 of 175,770- K110110 — ATRIUM CENTRILFX MESH
- K110176 — AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
- K110287 — PHILIPS ECG LEADWIRE SET
- K100184 — FUSTAR STEERABLE INTRODUCERS
- K102045 — DIMENSION VISA HBA1C, MODEL K3105A
- K103084 — NEODENT GRAFT SCREW
- K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
- K103379 — TELIO CS INLAY & TELIO CS ONLAY
- K103491 — SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
- K093745 — ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
- K093867 — ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
- K100144 — THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
- K101160 — ROCHE ORAL FLUID COCAINE
- K101818 — 4CIS VANE SPINE SYSTEM
- K102321 — DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
- K102449 — BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
- K102471 — AS3700 ANESTHSIA DELIVERY SYSTEM
- K102714 — COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
- K102750 — O2-IN-A-BOX, O2-IN-A-BOX
- K103000 — SMART READ BIOLOGICAL TEST PACK
- K103171 — ELECSYS ANTI-TPO CALSET
- K103238 — 1.5T OPTIMA MR430S
- K103330 — BRIVO MR355, OPTIMA MR360
- K103345 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)
- K103346 — DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
- K103352 — VERSAFITCUP CC TRIO
- K103386 — MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
- K103761 — VISUALIZE: VASCULAR
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.