FDA 510(k) clearances — page 167
clearances on record, most recent first.
Clearances — page 167
16,601–16,700 of 175,699- K210972 — H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two
- K210986 — H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit
- K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
- K211459 — syngo.via MI WorkFlows, Scenium, syngo MBF
- K211469 — Callaly Tampliner
- K211590 — Fiducial Marker
- K203815 — ELEOS Limb Salvage System with BioGrip
- K210591 — Palm Bladder Scanner - PBSV7.1
- K211216 — Vivid S60N / Vivid S70N
- K211441 — Navigated Anterolateral Disc Prep Instruments
- K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
- K202126 — Disposable Surgical Mask
- K210458 — OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
- K211062 — Medical Face Mask
- K211476 — ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
- K193383 — SnugKap
- K201914 — HRVWatch-Mini Wrist Monitor
- K202580 — Disposable Surgical Mask
- K202663 — Suture Wing
- K203802 — X-Pac Expandable Lumbar Cage System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.