FDA 510(k) clearances — page 769
clearances on record, most recent first.
Clearances — page 769
76,801–76,900 of 175,825- K013543 — BOND-1 C & B
- K013919 — TORFLEX TRANSSEPTAL GUIDING SHEATH
- K013975 — CP-SLEEVE
- K013993 — NEOCALEX
- K014027 — OPTIBOND SOLO PLUS 4
- K014033 — EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
- K014042 — D.SIGN 84
- K014079 — DR. HAYS BITE GUARD
- K014174 — HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33
- K020092 — TEMPHASE
- K020161 — AGILTRAC .018 PERIPHERAL DILATATION CATHETER
- K020240 — SLIM GLIDING NAIL SYSTEM
- K020266 — INION CPS BSSO SCREW
- K020274 — WMT MODULAR ULNAR HEAD IMPLANT
- K020407 — LORENZ BLUE DEVICE
- K020412 — DEPILASE TWIN LASE LASER SYSTEM
- K020436 — PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
- K012487 — SPHYGMOCOR PX MODEL SCOR-PX
- K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
- K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
- K013862 — BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
- K014102 — PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
- K020018 — MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
- K020197 — MODIFICATION TO DATACAPTOR
- K020204 — TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189
- K020494 — MODIFICATION TO M2376A DEVICELINK SYSTEM
- K003744 — ENRAF-NONIUS ENDOMED 182 SYSTEM
- K011273 — SI ASCOPE
- K011708 — MODIFICATION TO WARTNER WART REMOVAL SYSTEM
- K013259 — PORTABLE NON-CONTACT TONOMETER, MODEL PT100
- K013360 — DFINER UROLOGICAL CATHETER
- K013547 — BABYCOM
- K013930 — NEUROSENSOR
- K013997 — UNIFIL BOND
- K014202 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K020087 — SYNTHES CRANIAL PLATES
- K020143 — VASOVIEW 5 HARVESTING CANNULA
- K013219 — PROTOCO2L INSUFFLATOR MODEL 6400
- K013863 — CRYSTAL MONITOR MODEL 16
- K013874 — CLEARPLANE EASY OVULATION TEST
- K013970 — PRIME-DENT HEMA DESENSITIZER
- K014167 — LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
- K014239 — MEDSURG EQUIPMENT COVERS
- K014249 — JETPOLISHER
- K014252 — JETSTREAM
- K014258 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K014293 — K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
- K020080 — BONART ART-E1 ELECTROSURGERY UNIT
- K020277 — SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
- K020328 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)
- K011147 — CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)
- K011833 — MB 103 MILLENNIUM BLADES
- K011863 — VCS-A SERIES CLAMP
- K012472 — A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
- K013276 — ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
- K013342 — EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
- K013397 — PACIFIC HEMOSTASIS REFERENCE EMULSION
- K013825 — CANDELA SMOOTHBEAM LASER SYSTEM
- K014005 — APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
- K014173 — SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
- K014284 — NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE
- K020122 — MB 102 MILLENNIUM BLADES
- K020144 — SIEMENS INFINITY SC 6002XL MODIFICATIONS
- K020196 — MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
- K020234 — A1CNOW FOR RX HOME USE
- K020235 — A1CNOW FOR PROFESSIONAL USE
- K020251 — PARAGON INFUSION SYSTEM
- K020385 — CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
- K011239 — GINDA GUARD
- K012581 — REPROCESSED STONE RETRIEVAL BASKETS
- K012685 — REPROCESSED ENDOSCOPIC ELECTRODES
- K013542 — DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
- K014036 — MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
- K014129 — PROMOGRAN MATRIX WOUND DRESSING
- K014285 — NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE
- K020050 — ENAMEL BONDING SYSTEM
- K020062 — XERAFIT
- K020127 — SMARTFLOW PULSE TRANSMISSION COEFFICIENT
- K020236 — MODIFICATION TO PASS SPINAL SYSTEM
- K020293 — OSTEONICS SPINAL SYSTEM
- K020304 — DISPOSABLE LIGHT HANDLE AND ADAPTOR
- K020317 — NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
- K013301 — UNI-T SPINAL SYSTEM
- K013312 — P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
- K013803 — FLOWGUARD DEVICE
- K013979 — SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
- K013998 — POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
- K014073 — HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
- K014107 — ENDIUS CERVICAL PLATE SYSTEM
- K014185 — AOS CANNULATED BONE SCREW SYSTEM
- K014288 — DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
- K020353 — OMNIA X/XS ULTRASOUND SYSTEM
- K994055 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K010452 — BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
- K011835 — COBE REVOLUTION
- K011974 — SENSAID
- K012003 — DRG REACTION CHAMBER/SAFETY TIP
- K012368 — AEROPEP
- K012490 — ORION DIGITAL IMAGING SYSTEM
- K012675 — REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.