FDA 510(k) clearances — page 823
clearances on record, most recent first.
Clearances — page 823
82,201–82,300 of 176,637- K002611 — SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
- K002715 — ECAT PET SCANNER
- K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
- K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
- K002811 — ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
- K003060 — PLASMAKINETIC GENERATOR
- K003065 — SEEDNET, MODEL EP6T5, EP5E5
- K003214 — SMITH & NEPHEW PISTONS
- K000620 — PBN FALLOPIAN TUBE CATHETER SYSTEM
- K000638 — RESPONDER 3000
- K000861 — CRANIOCAP
- K001408 — KSEA VASCULAR FIBERSCOPES
- K002130 — NIR BILIARY STENT
- K002188 — SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,
- K002325 — WUJIN #3 TIBIAL NAIL
- K002356 — NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
- K002676 — ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
- K003061 — SYNTHES USS (10.0MM SIDE OPENING SCREWS)
- K003159 — CORDIS SLALOM PTA BALLOON CATHETER
- K000317 — SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
- K001179 — SUPER NOVA, ACUBEAM
- K001972 — ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
- K002424 — 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
- K003006 — TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
- K003076 — MITEK CUFFTACK
- K002316 — PHOENIX DIGITAL EEG
- K002367 — HARDY DISK CEFTIZOXIME, 30MCG
- K002369 — HARDYDISK GENTAMICIN, 120MCG
- K002376 — ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
- K002531 — EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
- K002560 — SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
- K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
- K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
- K002564 — SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
- K002577 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
- K002646 — ABX MICROS CRP
- K002660 — HARDYDISK LOMEFLOXACIN, 10MCG
- K002661 — HARDYDISK CEFOTETAN, 30MCG
- K002664 — HARDYDISK LEVOFLOXACIN, 5MCG
- K002702 — NEUROTOLOGY DRAPE, MODEL TBD
- K002880 — 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
- K003194 — STACKHOUSE LENS HOOD, MODEL SA-700/FS
- K003232 — RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
- K993101 — LITEAIRE
- K994390 — GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
- K001096 — BURR HOLE COVER, MODEL XX
- K001295 — PIPER
- K001493 — DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
- K001811 — NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
- K001884 — DIRECT CROWN
- K002310 — CARDIOBEEPER CB12/12, MODEL CB12/12
- K002335 — NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
- K002368 — HARDYDISK STREPTOMYCIN, 300MCG
- K002372 — ACCESS ALERT GAUGE
- K002483 — POWER 5000 GENERAL PURPOSE COIL
- K002522 — OPART, MODEL MRT-600
- K002558 — K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
- K002656 — HARDYDISK CEFUROXIME, 30MCG
- K002675 — MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM
- K002918 — OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
- K002982 — OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
- K003004 — OSCAR 2, MODEL 222
- K003012 — RAICHEM PHOSPORUS REAGENT
- K003094 — FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
- K003219 — HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
- K003221 — HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
- K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
- K000418 — PDT DOSECALCULATOR, MODEL 80000
- K000739 — EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
- K001070 — RADIOMED SOURCE
- K001693 — LIFE SCOPE P, MODEL BSM-4100 SERIES
- K002284 — VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
- K002431 — ELRAN 01 SYSTEM
- K002492 — SIMPLICITY SOFT INFUSION SET
- K002826 — EQUITY
- K002903 — ANSPACH ANGLED MICRONOSE ATTACHMENT
- K002975 — DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL
- K003091 — MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
- K003152 — SOMATOM SMILE
- K983783 — HEATED HUMIDIFIER
- K000838 — DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001163 — DMLC IV-ERGO
- K001468 — ELECSYS CA 15-3 TEST SYSTEM
- K001741 — RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
- K001990 — DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
- K002261 — MR-III
- K002278 — BROOKER FEMORAL NAILS
- K002341 — THERMAL CAUTERY UNIT, MODEL 150
- K002389 — BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
- K002446 — RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
- K002500 — X-POSURE SYSTEM VERSION 2 RAD
- K002542 — REUSABLE CANNULA
- K002589 — OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
- K002622 — BIOSLEEP
- K002631 — ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
- K002773 — NEUROMAP WITH NEURO 100
- K002788 — KSEA NEURO-FIBERSCOPE
- K002943 — WHEELCHAIR, MECHANICAL SERIES MODEL 3100
- K002980 — MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
- K993094 — AERO-CLICK
Data sourced from openFDA. This site is unofficial and independent of the FDA.