FDA 510(k) clearances — page 614
clearances on record, most recent first.
Clearances — page 614
61,301–61,400 of 176,637- K062626 — CORTISOL ELISA
- K062811 — DPILOG, MODEL DPC-512
- K062841 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
- K062847 — BIOGEL ECLIPSE INDICATOR UNDERGLOVE
- K063015 — AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
- K063068 — FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
- K063072 — CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES
- K063073 — CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
- K063616 — TRIDENT II ACETABULAR SYSTEM
- K063619 — FLIPPER DETACHABLE EMBOLIZATION COILS
- K063750 — XCEL 255 SLIT LAMP
- K062038 — X-STEN MILD TOOL KIT, MODEL MTK-0001
- K062198 — SUNSPOTS PRE-GELLED SURFACE ELECTRODES
- K062635 — MODEL 2200
- K062645 — RUIKE, MODEL 3431
- K062821 — U-CLIP DEVICE
- K062836 — CITADEL ANTERIOR LUMBAR PLATE SYSTEM
- K062838 — VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
- K062936 — NOBELPERFECT CONICAL CONNECTION
- K063136 — NEEDLELESS SLING
- K063229 — REST ASSURED NITE PROTECTOR
- K063331 — BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
- K063497 — MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
- K063499 — MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
- K063600 — VISTA AVS
- K060794 — PROGENIX DBM PUTTY AND PASTE
- K060795 — SOMNOFIT
- K061082 — MOBIS SPINAL IMPLANT
- K061737 — LOSS OF RESISTANCE SYRINGE
- K062929 — QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
- K062971 — BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
- K063049 — SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
- K063506 — LORENZ STERNAL CLOSURE SYSTEM
- K063640 — KOWA SL-15
- K061462 — BF+ (PH)
- K061656 — LASER-D68
- K061680 — ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
- K061879 — SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM
- K062345 — CERAMIC BOND
- K062426 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K062460 — VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III
- K062502 — OSSPRAY CLEANING COMPOUND
- K062524 — OCTAX LASER SHOT SYSTEM
- K062551 — NEXUS IRRIGATION TUBING SET
- K062577 — V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
- K062714 — SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW
- K062814 — PIPELINE II ACCESS SYSTEM
- K063446 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K063478 — VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)
- K063591 — VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
- K061283 — PULMOLIFE
- K061901 — INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
- K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K062333 — LAIMAD
- K062380 — FLOSIMPLE ARTHROSCOPY PUMP A120
- K062582 — SUPRACOR BALLOON CATHETER
- K062640 — STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
- K062676 — RUIKE, MODEL 3331
- K062770 — COPILOT HEALTH MANAGEMENT SYSTEM
- K062891 — PROTON THERAPY SYSTEM
- K062897 — C-U2
- K062947 — HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES
- K062969 — MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
- K063020 — INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM
- K063034 — AIR-FLEX WITH AUTO-DISTRACTION
- K063070 — APERFIX TIBIAL IMPLANT WITH INSERTER
- K063218 — E-CHECK (XE)
- K063270 — RPM RESPIRATORY GATING SYSTEM
- K063371 — PRONTO V3 EXTRACTION CATHETER, MODEL 5003
- K063482 — CROSSPLAN / ACCUSOFT-XL V.4.04
- K063558 — PEAK SE, MODEL 5135
- K063579 — 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC
- K063580 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
- K061774 — NFIX II PEDICLE SCREW SYSTEM
- K062177 — ZOLL E SERIES WITH REAL CPR HELP
- K062217 — AESKULSKA BETA2-GLYCO-A
- K062612 — RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
- K062692 — BIS BILATERAL SENSOR
- K062708 — QUANTA LITE CELIAC DGP SCREEN
- K062845 — MODULAR REPLACEMENT ELBOW SYSTEM
- K062856 — TF ROTARY NICKEL TITANIUM FILE
- K062922 — MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
- K063343 — BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
- K063426 — V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10
- K063479 — ARTHREX PUSHLOCK
- K052298 — CYSTOGLIDE INTRODUCER SHEATH
- K052465 — REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
- K061033 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
- K061889 — BIOSTAR OIA SHIGATOX
- K062951 — TAP III ANTI-SNORING DEVICE
- K063028 — VECTORVISION HIP SR
- K063080 — TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
- K063221 — MEDWEB ADVANCED 3D WEB PACS
- K063253 — RCHIVE PACS
- K063274 — ACCULOC BREAST LOCALIZATION SYSTEM
- K063337 — OPAL-RAD
- K063392 — IMCO-STAT
- K063414 — MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
- K063505 — VISUALASE ENVISION SOFTWARE SYSTEM
- K063513 — ECHELON MR-RCC-150 CARDIAC COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.