FDA 510(k) clearances — page 175
clearances on record, most recent first.
Clearances — page 175
17,401–17,500 of 176,479- K210050 — Augmented VaultLock Glenoid
- K210372 — Disposable Surgical Mask
- K210433 — Surgical Face Mask (Ear loops and Tie-on)
- K210641 — Disposable Medical Mask
- K200694 — Perfect EMS
- K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
- K201842 — TruBase S
- K202217 — Kendall NPWT Incision Management Device
- K202596 — Insulia Diabetes Management Companion
- K202763 — Fix2Lock (PEEK Self Punching)
- K202828 — Surgical Green Laser System
- K203388 — Disposable medical mask
- K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw
- K203704 — Surgical face mask
- K210014 — Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
- K210080 — Dentis s-Clean s-Line Mini
- K210613 — HIT Clear Aligner
- K211028 — Nitrile Patient Examination Gloves
- K211081 — AlphaVac Multipurpose Mechanical Aspiration (MMA) System
- K211108 — Prudent 1717, Prudent 1417, Prudent 1212
- K211303 — Avon Patello-femoral Joint Prosthesis
- K211410 — GlidePath 13F Long-Term Hemodialysis Catheter
- K211473 — Micro C Medical Imaging System, M01
- K200722 — PCA-C1 series Patient Cable
- K202128 — Allmed Surgical Face Masks (Ear loops)
- K210604 — Intellihab System
- K210627 — Breezeway II
- K211323 — ASTRA Spine System
- K211401 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- DEN200069 — Cognoa ASD Diagnosis Aid
- K200891 — BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
- K203190 — Surgical Face Mask
- K203229 — NATRELLE INSPIRA Single Use Sizers for Gel Implants
- K210150 — Disposable Medical mask
- K210404 — Transpara 1.7.0
- K210429 — Disposable Surgical Face Mask
- K210583 — SeaSpine WaveForm A Interbody System
- K210652 — 6MS Invisible Aligner
- K211051 — DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
- K211372 — Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
- K211440 — ASM-301 Level 3 Surgical Mask
- K200942 — Well-Life Garment Electrodes (GM Series)
- K210994 — Arthrex Beveled FT Screws
- K200607 — LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
- K202932 — ABT12 multi-purpose solution
- K203687 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
- K210025 — INVU by Nuvo
- K210188 — coraCross
- K210289 — Infant Phototherapy Equipment
- K210536 — Irrisept Antimicrobial Wound Lavage
- K210917 — Single Use Injection Needle
- K211261 — Axis Charcot Fixation System
- K211301 — Pathfinder Endoscope Overtube
- K211304 — LINQ II Insertable Cardiac Monitor
- K211311 — AtriCure Isolator® Synergy Surgical Ablation System
- K211344 — MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
- DEN190043 — SafeBreak Vascular
- K200704 — ZedView
- K201639 — Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
- K202765 — ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
- K211057 — LigaPASS® Spinal System, CD Horizon Spinal System
- K211134 — BIB Stent Placement Catheter
- K211282 — Aqua Medical RF Vapor System
- K211307 — GalaSTITCH Absorbable Monofilament Suture
- K202832 — Implacil Implant System
- K203196 — Peak flow meter
- K203322 — SpyGlass Discover Retrieval Basket
- K210051 — OTE MPS 045 Multi-purpose Lens Care Solution
- K210520 — Disposable Synthetic Examination Gloves
- K211098 — Breast Volume Navigator (BVN) Model G-2000
- K211251 — ViperCath XC Peripheral Exchange Catheter
- K211253 — PlasmaWave
- K211258 — Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System
- K211292 — Fassier-Duval Telescopic IM System
- K203144 — MicroPen EVO
- K203724 — HeRO Graft, HeRO Adapter
- K203760 — Tokuyama Universal Bond II
- K210608 — LUX-Dx Insertable Cardiac Monitor
- K210915 — Pathfinder Endoscope Cap
- K210977 — E-Dent 1000
- K211275 — AirMax Procedure Mask
- K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
- K211460 — Air Relax Plus Model AR-3.0
- K210214 — NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System
- K210425 — Catalyft PL Expandable Interbody System
- K210535 — UltraLight LED System
- K210975 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
- K211246 — LEGION CR Porous Plus HA Femoral Components
- K190703 — Neuro-IOM system with Neuro-IOM.NET software
- K201192 — Impla-NX (Model: ISE-270M)
- K201461 — Manual Wheelchair, Model A011
- K202299 — Ultrasonic Surgical Aspirator System
- K202359 — Zio Monitor
- K202527 — Zio ECG Utilization Software (ZEUS) System
- K203806 — JWX-1 Plus (Navigo 16/Navigo 24)
- K210119 — IPL Hair Removal Device (Model: KCA423)
- K210358 — Neurescue device
- K211273 — Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
- K211312 — Universal Viewer
- K211423 — Rover
Data sourced from openFDA. This site is unofficial and independent of the FDA.