FDA 510(k) clearances — page 657
clearances on record, most recent first.
Clearances — page 657
65,601–65,700 of 176,637- K051186 — MICROPULSE PHACOEMULSIFICATION SYSTEM
- K051305 — CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5
- K051337 — EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001
- K051344 — COLONIC AND ENEMA NOZZLE
- K051824 — INVADER UGT1A1 MOLECULAR ASSAY
- K051973 — MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
- K051996 — DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30
- K052166 — MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM
- K050644 — VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
- K051178 — MEE-1000A NEUROMASTER
- K051522 — SILBRONCHO DOUBLE LUMEN TUBE
- K051597 — STRATUS CS D-DIMER
- K051706 — IQ BODY FLUIDS CONTROL
- K051758 — PENUMBRA ASPIRATION PUMP, MODEL 115V
- K051793 — ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)
- K051901 — NIO 3MP-21
- K051918 — RESOLVE OPEN BACK HALO RINGS
- K051985 — BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
- K052021 — V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER
- K052069 — PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
- K052111 — XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
- K050183 — SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
- K050222 — VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
- K050493 — QUANTIA IGE
- K050613 — QUANTIA BETA-2 MICROGLOBULIN
- K050821 — COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
- K050840 — MODIFICATION TO DUET SYSTEM
- K050971 — BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
- K051095 — 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K051282 — VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU
- K051364 — VPAP ADAPT
- K051526 — URITEK-720+ URINE ANALYZER
- K051633 — CD-CHEX PLUS BC
- K051794 — GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
- K051849 — VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
- K051923 — POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED)
- K051930 — DRUG ACCESS SPIKE
- K052034 — TERUMO SYRINGE WITH/WITHOUT NEEDLE
- K052038 — PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
- K052044 — ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
- K052054 — TSRH SPINAL SYSTEM
- K052071 — LYSUS INFUSION SYSTEM
- K052077 — G-SCAN CERVICAL SPINE COIL
- K052096 — NUBIC SPINAL IMPLANT
- K052128 — 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
- K052165 — RX ACCUNET EMBOLIC PROTECTION SYSTEM
- K043015 — 3L SURGICAL DRAPES
- K043259 — BIOBLANKET SURGICAL MESH
- K050262 — U2 ACETABULAR COMPONENT
- K050320 — FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT
- K050575 — FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
- K050798 — ECLIPSE NEUROLOGICAL WORKSTATION
- K051131 — VCS S3T
- K051302 — EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
- K051420 — HABIB 4X
- K051613 — MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3
- K051615 — STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES
- K051700 — OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR
- K051709 — HIPPOCAMPE WHEELCHAIR
- K051786 — MELIDE FIBEROPTIC LIGHT
- K051809 — EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM
- K051813 — ULTRAPACS
- K051819 — C CHANGE SOLUTION WARMER
- K051840 — ENSITE VERISMO SOFTWARE
- K051972 — KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
- K052130 — VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
- K043260 — ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
- K050899 — BIOGEL LATEX STERILE POWDER-FREE GLOVE
- K051038 — 506 PATIENT MONITOR
- K051129 — DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
- K051606 — GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
- K051703 — CLEVER TD-3018A BLOOD PRESSURE MONITOR
- K051748 — HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
- K051777 — NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
- K051827 — JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE
- K051897 — TRIO MONITOR
- K051900 — ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
- K051932 — ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
- K052097 — CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE
- K050869 — MODIFICATION TO ABL800 FLEX
- K050984 — BIOPLANT
- K051071 — VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
- K051135 — AXIOM NVP8500
- K051169 — BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
- K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER
- K051505 — SCB/STERIS OR-LIGHT INTERFACE BOX
- K051533 — I-STOP
- K051644 — VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR
- K051766 — ORTHOMEND
- K051848 — SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
- K051902 — NIO 2MP-21
- K052001 — MODEL SR-115 PORTABLE X-RAY SYSTEM
- K052039 — GE OEC ALTITUDE
- K052100 — MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
- K052109 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)
- K050250 — AQUIFY MULTIPURPOSE SOLUTION
- K050824 — 100W CERALAS D 980 LASER SYSTEM, MODEL D100
- K051479 — RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
- K051605 — SBI K-WIRES
Data sourced from openFDA. This site is unofficial and independent of the FDA.