FDA 510(k) clearances — page 824
clearances on record, most recent first.
Clearances — page 824
82,301–82,400 of 176,637- K000246 — RADIOCAMERAS EXTRACRANIAL SYSTEM
- K000963 — DA VINCHI EEG AND EMG/EP SYSTEMS
- K001646 — PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
- K002229 — WACKERS-LIU CQ SOFTWARE
- K002423 — LACTOSORB PUSH SCREW
- K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
- K002581 — DURAGARD SODIUM FLUORIDE VARNISH
- K002814 — DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K002888 — NICHOLS ADVANTAGE THYROGLOB
- K002949 — MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
- K003104 — BACT/ALERT CSR
- K003121 — MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
- K003125 — SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
- K991124 — VISIJET HYDROKERATOME, MODEL 50
- K994276 — BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)
- K994281 — BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)
- K994320 — CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
- K000632 — 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
- K000696 — MACROPOREMX MANDIBULAR FIXATION SYSTEM
- K000730 — IMPOAID
- K001552 — TREPCHEK TREPONEMAL ANTIBODY EIA
- K001668 — GLOBAL SPINAL FIXATION SYSTEM
- K001795 — THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
- K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
- K002189 — GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
- K002257 — TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
- K002358 — MDI GLIADIN A TEST
- K002359 — MDI GLIADIN G TEST
- K002471 — JETCAN HUBER NEEEDLE SET
- K002479 — BIOMESH P1 AND BIOMESH PLUG AND PATCH
- K002519 — VITREA 2, VERSION 2.1
- K002566 — LUMALITE CURE LIGHT, MODEL 2100
- K002613 — MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
- K002645 — JEL BIOS PURE
- K002663 — HARDYDISK NETILMICIN, 30MCG
- K002905 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
- K002933 — STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
- K003010 — SPIRIT ACUPUNCTURE NEEDLE
- K003107 — M2376A DEVICELINK SYSTEM
- K003225 — SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
- K000855 — GUNTHER TULIP VENA CAVA MREYE FILTER SET
- K001522 — TRANSQ3
- K002204 — PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
- K002330 — NAVIGUS PEEL AWAY INTRODUCER
- K002443 — COLLAGEN WOUND DRESSING
- K002444 — PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
- K002510 — SMARTLENS
- K002534 — EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
- K002686 — ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
- K002700 — KSEA UNIMAT 12
- K002849 — PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
- K002921 — SUREONE INSULIN SYRINGE
- K002957 — SOLAR SPO2 MODULE WITH MASIMO SET
- K002967 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K003090 — MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
- K000252 — INSIGHT 4000 ENDOSCOPE
- K000929 — PROLITE PULSED LIGHT SYSTEM
- K002198 — FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS
- K002408 — AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
- K002420 — HITACHI ALTAIRE
- K002482 — VISION 9000 PHASED ARRAY TORSO COIL
- K002823 — RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
- K002828 — XPS NITRO SYSTEM
- K002898 — CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
- K002913 — HEADBAND FOR BAHA
- K002936 — MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
- K994121 — SMALL STATURE USS
- K002870 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K002922 — OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)
- K002959 — MODIFICATION TO ISOBAR SPINAL SYSTEM
- K000666 — TC-PLUS SOLUTION KNEE
- K001578 — ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
- K002147 — FOCUS
- K002168 — ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
- K002180 — SIMPLICITY DISPOSABLE PEN NEEDLE
- K002233 — BVI SLING
- K002396 — ENDOCARE PERCUTANEOUS ACCESS SET
- K002467 — COALIZA PROTEIN S-FREE
- K002562 — PACIFIER THERMOMETER MODELS VT-901F, VT901C
- K002651 — C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
- K002858 — XIA SPINE SYSTEM
- K002871 — MODIFICATION TO YASARGIL ANEURYSM CLIPS
- K002882 — HL168B
- K002883 — PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K002909 — ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
- K003022 — AERONEB PORTABLE NEBULIZER
- K003054 — AUTOSTAT II ENA-6 PROFILE ELISA
- K003057 — AUTOSTAT II ENA-4 PROFILE ELISA
- K980974 — SAFE MINI
- K994059 — CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
- K002133 — NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
- K002143 — DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
- K002191 — CARRIAZO BARRAQUER II MICROKERATOME
- K002737 — SMITH & NEPHEW PORPS & TORPS
- K002745 — VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
- K002855 — BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
- K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST
- K003014 — SOMATOM EMOTION MS
- K000995 — NARKOMAT, MODEL 2000
- K001835 — IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.