FDA 510(k) clearances — page 373
clearances on record, most recent first.
Clearances — page 373
37,201–37,300 of 176,542- K143156 — Sentinella 102; Sentinella 102 Horus
- DEN140025 — BrainScope Ahead 100
- K133827 — A-LINK Z
- K140222 — SAIPH KNEE SYSTEM
- K140586 — ASCEND ELECTRODE
- K140595 — THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
- K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT
- K141317 — ZIP MIS INTERSPINOUS FUSION SYSTEM
- K141606 — SURGICAL GOWN
- K141839 — PREMIER ETCH
- K142099 — CUTANEOUS ELECTRODES
- K142292 — Speed, Speed Shift, Speed Titan, Speed Arc
- K133446 — HEPARIN LOCK / FLUSH SYRINGES
- K140078 — TECOTHERM NEO (T NEO)
- K140424 — RESPIRONICS REUSABLE HEATED TUBING
- K140438 — MICRO GUIDE CATHETER ELITE
- K141076 — GARMENT ELECTRODES
- K141299 — OTC COMBO TENS/EMS SYSTEM
- K141341 — CL DETECT RAPID TEST
- K141342 — WEARABLE THERAPY GARMENTS
- K141471 — JOURNEY II XR KNEE SYSTEM
- K141617 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- K141968 — NUVASIVE NVM5 SYSTEM
- K141994 — BULK FILL FLOWABLE COMPOSITE
- K142093 — V20 SYSTEM
- K142161 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
- K142315 — MINOP Disposable Introducer 26F
- K142413 — TITAN Modular Total Shoulder System
- K142462 — Restoration Anatomic Shell
- K142565 — Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter
- K142601 — Panorama Patient Monitoring Network
- K142810 — WEGO-PGCL Absorbable Surgical Monofilament Suture
- K142908 — Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
- K132691 — ABL90 FLEX
- K133175 — DRAEGER JAUNDICE METER JM-105
- K133643 — SYNGO, CT LIVER ANALYSIS
- K133896 — REJUVALITE MD
- K140352 — VERAPLUG
- K140439 — OMNIPOD INSULIN MANAGEMENT SYSTEM
- K140466 — PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300
- K140492 — NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
- K141593 — UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
- K141718 — INTERNAL HYDRATING GEL
- K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
- K142066 — AERO-LL LUMBAR CAGE SYSTEM
- K142115 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
- K142219 — GammaBeam 100
- K142254 — CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
- K142265 — ONE Snare Endovascular Microsnare System
- K142428 — Shock Pulse-SE Lithotripsy System CYBERWAND II
- K142513 — Barricade Embolization Coil System
- K142658 — Biomet Headless Compression and Twist-off Screws
- K133929 — HEALTH EXPERT ELCTRONIC STIMULATOR
- K140807 — COMPOSITE ORTHODONTIC BRACKETS
- K140934 — HIOSSEN IMPLANT SYSTEM
- K141038 — ANT MODEL 1
- K141457 — DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
- K141571 — ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
- K142047 — EIDON
- K142301 — Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
- K142593 — AngioVac Cannula
- K142836 — Zimmer Plates and Screws (ZPS), Forte Screws
- K142903 — neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
- K143076 — 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
- K143157 — Coronis Fusion 4MP LED
- K140951 — YEESCOPE LARYNGOSCOPES
- K140961 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
- K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP
- K141503 — DENALI 501CEMENT
- K141877 — LEAF PATIENT MONITORING SYSTEM
- DEN100024 — ZAP-IT!
- DEN130019 — ZANZA-CLICK
- K133980 — PANTHEON ELECTROSTIMULATOR
- K140389 — CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
- K140732 — CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
- K141644 — INNOVASIS CRANIAL SYSTEM
- K141771 — PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
- K141942 — MIDLINE II TI
- K141967 — PUREFILL OXYGEN COMPRESSOR
- K141990 — ENCORE HUMERAL SHOULDER STEM
- K142139 — SMR 40MM GLENOSPHERE
- K142215 — Power Twin21-50/Power Twin21-100
- K142550 — EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
- K143001 — SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
- K133166 — INS HILDEN TIBIAL ARZZT
- K133898 — NIOX VERO AIRWAY INFLAMMATION MONITOR
- K140130 — X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED
- K140244 — YONGHE
- K140246 — YONGFA
- K140355 — SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
- K140502 — ZOLL E SERIES ALS
- K140691 — IG_PLEX CELIAC DGP PANEL
- K140727 — CUTERA PICOSECOND LASER SYSTEM
- K140853 — STIMPOD ST2-3010 NERVE STIMULATOR
- K141555 — ADVANTAGE
- K141668 — CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K141674 — CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K141887 — OBSIDIAN PRESS (ALL CERAMIC AND POM)
- K141993 — NAKOMA ACP
- K142016 — CAPRI
Data sourced from openFDA. This site is unofficial and independent of the FDA.