FDA 510(k) clearances — page 866
clearances on record, most recent first.
Clearances — page 866
86,501–86,600 of 176,637- K992508 — TSX PROBE, OCULAR CONTACT PROBE; TSX PROBE,OCULAR CONTACT PROBE,SMA
- K992541 — LAPAROCAM
- K990565 — SUZANNE
- K991273 — SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
- K991283 — DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
- K991585 — BIPOLAR SHOULDER PROSTHESIS
- K991719 — EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
- K991769 — CUTANEOUS (BAR) ELECTRODE
- K991770 — CUTANEOUS (GROUND) ELECTRODE
- K991771 — DIGITAL RING ELECTRDE
- K991772 — CUTANEOUS (DISC) ELECTRODE
- K991875 — K-L-W INTRAORAL DISTRACTOR
- K992114 — KSEA CALCUSPLIT
- K992118 — PRODIGY 4 TRANSLUCENT SHADES
- K992160 — NEXUS 2
- K992327 — DUTECK DIGITAL CLINICAL THERMOMETER
- K992391 — UROSURGE SPIRALFLO URETERAL STENT
- K992411 — ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
- K992446 — DAILIES (NELFILCON A) ONE-DAY
- K992500 — CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
- K990359 — KONICA DIRECT DIGITIZER, MODEL DD-341
- K991693 — TWO RIVERS POWER LIFT/RECLINE CHAIR
- K991753 — MAXIM REMOVABLE MOLDED POLY TIBIA
- K991764 — SOMATOM PROJECT 10-CT SCANNERS
- K991785 — MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
- K991873 — KMI WRIST FUSION SYSTEM
- K991980 — MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
- K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
- K992152 — GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF
- K992200 — TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
- K992337 — BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
- K992412 — IPASS BOLUS TRACKING
- K992515 — EBI XFIX DFS OPTIROM ELBOW FIXATOR
- K983298 — BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
- K992048 — MODIFICATION OF PROMPT L-POP
- K992339 — COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
- K982860 — UM-L20/ UM-L30
- K983577 — ARTHREX MENISCAL DART SYSTEM
- K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
- K990178 — BURNFREE PAIN RELIEVING GEL, MODEL 4B
- K990179 — BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
- K990180 — BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING
- K990651 — SKIN 2 FORTE SILICONE SHEETING
- K990724 — CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
- K991427 — PARAMED PARAFFIN WARMER
- K991685 — HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
- K991721 — EBI OMEGA 21 SYSTEM
- K991738 — DIGITAL VIDEO RECORDING SYSTEM
- K991794 — ENDOSCOPIC SPINAL ACCESS SYSTEM
- K991815 — EXPLORER 3D
- K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES
- K991921 — INTERMITTENT COMPRESSION BOOT FOR OTC
- K991958 — KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
- K991960 — SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH
- K991972 — INFANT FLOW SYSTEM
- K992025 — PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
- K992046 — SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
- K992120 — DYNAWELL OR DYNAWELL
- K992336 — MONARCH II MINI MASK
- K992439 — NORODYN 8000 SEMG SYSTEM, ND-8000
- K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
- K982724 — THERADYNE ROVER POWERED WHEELCHAIR
- K982969 — NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
- K983395 — FETALGARD 3000 FETAL MONITOR
- K984304 — RIWO DRIVE GENERATOR
- K984567 — VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
- K984569 — AB2 MED-FLO SOLUTION SET
- K990428 — DRAINAGE BAG
- K990440 — GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
- K990907 — REMOTE INTRODUCER, MODEL PI-1000
- K991669 — PMS 750 FINGERSWITCH
- K991674 — CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
- K991678 — WHITESIDE BIOMECHANICS SPINAL SYSTEM
- K991718 — OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D
- K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
- K991791 — SOUND VASER SYSTEM
- K991792 — CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
- K991820 — HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
- K991889 — ULTIMAX HAIG II NAIL SYSTEM
- K991895 — RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
- K991920 — DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
- K991931 — CTD MARK I TRACTION DEVICE
- K991949 — LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
- K991950 — LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
- K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- K992035 — MANUAL WHEELCHAIR
- K992052 — MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
- K992109 — ENCORE FULLY COATED HIP
- K992346 — KINEMATIC II ROTATING HINGE KNEE
- K992363 — SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
- K992473 — EXPRESSEYE
- K992499 — GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
- K992514 — CONVERTORS BREATHABLE SURGICAL GOWNS
- K983333 — BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
- K983364 — BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
- K990545 — JETSONIC 2000
- K991268 — GONOSTAT GONOCOCCAL DETECTION KIT
- K991481 — PARAGON
- K991776 — NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
- K991779 — NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.