FDA 510(k) clearances — page 569
clearances on record, most recent first.
Clearances — page 569
56,801–56,900 of 176,542- K080088 — BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
- K080180 — MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
- K080330 — SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
- K080517 — RESICEM
- K080585 — DESKTOP PRO
- K080589 — SATURN 9000-810
- K080724 — GC OPB-100
- K080834 — VINTAGE ART
- K080881 — CURE CATHETER CLOSED SYSTEM
- K080888 — MODEIFICATION TO IPLAN RT DOSE
- K080931 — VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
- K080970 — USHIFU STEPPER
- K081091 — PRECISION 500D R&F X-RAY SYSTEM
- K081242 — 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
- K081297 — VERTEX RECONSTRUCTION SYSTEM
- K081304 — ALZ WEB PACS, VERSION 1.0
- K081379 — MODIFICATION TO INREACH SYSTEM
- K081427 — BROWNE OPA TEST STRIP
- K081482 — CSBP-001A BODY ORGAN PERFUSION SYSTEM
- K080550 — MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
- K080673 — INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
- K080755 — SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
- K081133 — KYMCO FORU, MODEL EQ40
- K081152 — T2 FEMORAL NAIL
- K081332 — ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
- K072852 — SL-PLUS STANDARD AND LATERAL HIP STEMS
- K072939 — HE4 EIA, MODEL: 404-10 US
- K073179 — SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
- K073501 — ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
- K080014 — CLEVER CHEK TD-3250C BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
- K080175 — NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
- K080230 — NEB-U-MASK SYSTEM, MODELS 1895, 1896
- K080366 — DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
- K080506 — MARTIN CHAIR, MODEL C4S1
- K080684 — WG-SURGICAL SUTURES WITH NEEDLE
- K080706 — CONNEXX LOCKING TIBIA NAIL
- K080773 — THOR ANTERIOR PLATING SYSTEM
- K080932 — MOSAIC LASER SYSTEM
- K081001 — PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
- K081002 — MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
- K081003 — TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
- K081037 — WATCH-PAT 200I (WP200I)
- K081318 — ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
- K070844 — NILIMEDIX ADI
- K072198 — X-VOID, SPIDER
- K073229 — NERVE MONITORING CABLE
- K073712 — SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
- K080146 — ZIRKONDENT
- K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
- K080384 — HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
- K080601 — ERGO++ VERSION 1.7
- K080677 — COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
- K080678 — UNI-KNEE 2.0
- K081032 — TR-USB TELEPHONIC STETHOSCOPE
- K081065 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
- K081296 — PREFERENCE PEDICLE SCREW SYSTEM
- K081399 — AVIATOR TRANSPORT INCUBATOR
- K081458 — PROVEN STEM EXTENDER
- K080478 — GRADIA FORTE
- K081285 — FINGER PULSE OXIMETER, MODEL 9560
- K081305 — MERCI RETRIEVER
- K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
- K073109 — STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM
- K073155 — VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
- K080072 — MRI PATIENT POSITIONING DEVICES
- K080859 — DRF 4343
- K080876 — DVX SPINE SYSTEM
- K080904 — FEEL-FINE INSULIN PEN NEEDLE
- K081055 — 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
- K081056 — 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
- K081121 — MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
- K081308 — FUJIFILM FCR VIEW, MODEL CR-VW674
- K081311 — POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
- K081417 — FOXCROSS PTA CATHETER
- K081426 — NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
- K071755 — FALCK APPLANATION TONOMETER (FAT2)
- K073708 — FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
- K080555 — SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
- K080772 — BONEMEDIK-DM
- K081044 — REJUVENATE MODULAR HIP SYSTEM
- K081097 — ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
- K081449 — ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
- K071916 — METHA HIP SYSTEM
- K072080 — NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
- K080539 — ACCIN UNIPOLAR HEAD SYSTEM
- K080703 — BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK
- K080973 — CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
- K081022 — SOMATOM DEFINITION, MODEL AS/AS+
- K063532 — BARD E LUMINEXX BILIARY STENT
- K063723 — IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
- K072178 — ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
- K072582 — PROVOX MICRON HME
- K073051 — MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
- K073078 — RAPID TOX CUP
- K073694 — IVENT 2001 MRI CONDITIONAL
- K073711 — MUCOGRAFT COLLAGEN MATRIX
- K080115 — I-MINI DENTAL IMPLANT
- K080129 — SECURE IMPLANT SYSTEM (2.5/3.0MM)
- K080198 — TSO3 OZONE STERILIZATION WRAP
- K080386 — COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.