FDA 510(k) clearances — page 25
clearances on record, most recent first.
Clearances — page 25
2,401–2,500 of 175,620- K253125 — Parietene Flat Sheet Mesh
- K253129 — Infinity OCT System
- K253150 — Cryon-X Cold Compression
- K253188 — CoaguChek XS Plus System
- K253335 — CD Horizon Spinal System
- K253377 — Expandable Titanium PLIF/TLIF System
- K250288 — TeraRecon Cardiovascular.Calcification.CT
- K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
- K252309 — PerQseal Introducers
- K252345 — Picosecond Laser Device (PF131-BI)
- K252384 — DESS® Dental Smart Solutions
- K252425 — Silatrix Oral Gel
- K252732 — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
- K252931 — Invisalign® Palatal Expander System
- K253100 — MultiPulse TFL
- K253226 — UV5000W Handle
- K250666 — Alegria Flash CTD Screen
- K250955 — XC11 ICE System, USA
- K251030 — Sirona Advanced Imaging Suite
- K251185 — Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
- K251289 — WELLlife COVID-19 Antigen Test Rx
- K251628 — Mandibular Advancement Device L07
- K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K251977 — electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
- K252298 — ANDI 2.0
- K252322 — SIros-X System
- K252325 — Hair Growth Laser Cap
- K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
- K252569 — Carrier XL Delivery Catheter
- K253144 — Freedom® Total Knee System Titan PCK Components
- K253145 — Pre-Sutured Tendon
- K253147 — FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
- K231897 — NeuroAlign software
- K250126 — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
- K250394 — Fine TTO
- K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
- K250887 — Neuromuscular Transmission Monitor TOF3D (2510091)
- K251838 — Introducer Sheath Set
- K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
- K253034 — HemoSphere Stream Module
- K253040 — Aevumed FASE Suture Anchor
- K253249 — TriALTIS Spine System
- K242827 — A8 INTEGR8 Porous Pedicle Screws
- K251414 — Miracu Polydioxanone (PDO) Suture and Needle (MONO)
- K252155 — AVAVA Skin Treatment System
- K252277 — Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)
- K252319 — Q-Switched Nd: YAG Laser machine (LFS-C13U)
- K252640 — VereSee Optical Veres Needle and Endoscopic Camera
- K252665 — brAIn Shoulder Positioning
- K253182 — InkSpace Imaging Small Body Array (SBA12PH30x)
- DEN240076 — Modius Lean
- K250145 — Biopsy Port Adapter
- K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
- K250178 — Adin Customized Abutments
- K250197 — Estremo Fibular Nail
- K250203 — SureAx-Guide
- K250227 — JOVS Electric Stimulation Beauty Device (JE2)
- K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II
- K250911 — MOSkin Radiation Measurement System
- K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
- K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550
- K251282 — StealthStation S8 Spine Software
- K251355 — X1-FFR
- K251673 — X9 Ultrasound System
- K251778 — Remi Custom Night Guard
- K251832 — InZone IST Detachment System; IZDS Connecting Cable
- K252075 — Program insite® Powder-Free, Disposable Nitrile Exam Gloves
- K252254 — Osteotomy Wedge System
- K252264 — MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)
- K252266 — S.I.N. Dental Implant System
- K242100 — SurgiAid Collagen Wound Dressing (HA)
- K243727 — Re:Balans
- K250731 — MateLaser Medical Diode Laser Systems (ML-DLS-30)
- K250852 — Coolfase
- K251497 — Elos Accurate Hybrid Base
- K251882 — Uterine Aspiration Set
- K251994 — Arthrex Synergy Vision Imaging System
- K252024 — NeurAxis IB-Stim (01-1020)
- K252093 — Light Therapy Mask (1019055)
- K252153 — FFX Facet Fixation System
- K252223 — Alpha Endo Handpiece (Alpha Endo)
- K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
- K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
- K252631 — Profoject Disposable Needle
- K253000 — CryoFreeze Wart and Skin Tag Remover
- K253024 — ProZip Knotless Implant
- K253114 — TargetCool (RM-DT02W)
- K250107 — V-soft Line Barbed Surgical Suture (Various)
- K250510 — Sure-Fine Insulin Syringes
- K250979 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
- K251294 — Bonafix Implant Abutments
- K251805 — syngo.CT Dual Energy
- K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
- K252199 — AGFA HealthCare Enterprise Imaging
- K252367 — InbellaMulti System
- K252920 — ELEOS Limb Salvage System with NanoCept® Technology
- K252944 — LOCATOR® Angled Abutment
Data sourced from openFDA. This site is unofficial and independent of the FDA.