FDA 510(k) clearances — page 863
clearances on record, most recent first.
Clearances — page 863
86,201–86,300 of 176,637- K982910 — HAMILTON MEDICAL GALILEOVENTILATOR
- K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING
- K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
- K991036 — DANEK PLATE AND SCREW SYSTEM
- K991066 — MADTRONIC DLP ARTERIAL CANNULAE
- K991125 — SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES
- K991419 — MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI
- K991529 — CSM STRETTA CONTROL MODULE ELECTROSURGICAL GENERATOR, MODEL S400
- K992050 — LUMENON XENON LIGHT SOURCE
- K992110 — PREMIER ANTERIOR CERVICAL PLATE SYSTEM
- K992128 — DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
- K992171 — COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
- K992437 — SCHOELLY RIGID ENDOSCOPES
- K992464 — SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
- K992540 — XENON LIGHT SOURCE PES 1
- K992557 — QUALATEX POWDERED LATEX EXAMINATION GLOVES
- K992661 — CONTROL III ELITE
- K992730 — HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
- K992807 — BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
- K992917 — AEROCHAMBER PLUS VALVED HOLDING CHAMBER
- K972708 — ENDO-SPOR PLUS / HYPROCIDE
- K973971 — KION ANESTHESIA SYSTEM
- K991218 — ORATEC BIPOLAR ABLATION PROBES
- K991388 — ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
- K991799 — DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
- K992057 — IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
- K992119 — BIO-MODULAR SHOULDER SYSTEM
- K992131 — SAMSUNG RAYPAX LONG TERM ARCHIVE
- K992194 — CORTICAL MAPPING UNIT, MODEL CMU
- K992307 — EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
- K992308 — OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
- K992311 — K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
- K992312 — K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
- K992417 — ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
- K992418 — ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI
- K992419 — ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
- K992743 — COLLINS CPL
- K992803 — SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
- K991375 — BARD BALLOON INFLATION SYSTEM
- K991990 — TRI-POLAR SYSTEM
- K991991 — DUPEL IONTOPHORESIS SYSTEM
- K991994 — TWILIGHT
- K992011 — SYNEA-HS HIGH SPEED-HANDPIECE
- K992015 — FREEDOM INFUSION SYSTEM
- K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
- K992210 — SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
- K992345 — CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
- K992358 — CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
- K992588 — BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
- K992630 — THERMALIGHT 2000
- K992693 — RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90
- K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
- K992721 — COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
- K990335 — PHILIPS EASYVISION WORKSTATION:
- K991020 — <GENX> DOUBLE LUMEN NEEDLE
- K991022 — <GENX> SPERM WASHING MEDIA
- K991262 — <GEN>SINGLE LUMEN NEEDLE
- K991264 — <GENX> SINGLE LUMEN SIDEPORT NEEDLE
- K991266 — <GENX> EMBRYO TRANSFER CATHETER CC GLIDER
- K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
- K991969 — HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)
- K991986 — COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
- K992027 — KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR
- K992038 — POCKETSPACER
- K992073 — AX WORKSTATION
- K992091 — PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
- K992112 — SAMSUNG RAYPAX FILM DIGITIZER
- K992237 — MEDTRONIC GT2 FUSION GUIDE WIRES
- K992802 — TERUMO U-100 INSULIN SYRINGE
- K992864 — RENDER-PLAN 3-D
- K991683 — PTFE RINGED GORE-TEX VASCULAR GRAFT
- K991754 — GO GLUCOSE MONITORING SYSTEM
- K991996 — IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
- K992013 — DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER
- K992044 — INFUSION DYNAMICS POWER INFUSER MODEL M100B
- K992090 — MILLENNIUM GOLD
- K992135 — SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
- K992259 — ECHOCARDIOGRAPHY SYSTEM SERIES 95000
- K992305 — MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
- K992379 — RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
- K992472 — SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM
- K992640 — SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS
- K992765 — CYNOSURE DIODERM
- K992893 — DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
- K992895 — IMPREGUM F
- K992897 — IMPREGUM PENTA
- K991901 — BIO-97
- K992170 — N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
- K992225 — QUANTITATIVE FLOW
- K992610 — GENDEX 765DC, MODEL 110-0154
- K992868 — DENTAPURE DP40 CARTRIDGE
- K980024 — SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
- K982926 — FRESENIUS BLOOD VOLUME MONITOR
- K984101 — FLEXIBLADE
- K984391 — THE LIBERATOR
- K990148 — STACKABLE CAGE SYSTEM
- K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM
- K990494 — MODIFICATION OF NOGA
- K990689 — ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
Data sourced from openFDA. This site is unofficial and independent of the FDA.