FDA 510(k) clearances — page 166
clearances on record, most recent first.
Clearances — page 166
16,501–16,600 of 176,479- K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
- K202790 — Syntec Orthodontic Mini Screw Extended System
- K203141 — Uramix CuraWay Biopsy Needle
- K203155 — BreatheSuite MDI V1
- K203418 — Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
- K203762 — Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
- K203845 — Philips IntelliSite Pathology Solution
- K210399 — Unifine SafeControl
- K210441 — Incontinence Probe
- K211158 — NTI ClenchGuard
- K211234 — RedEx
- K211751 — WELLTRUST WT-III Mask with Flat Earloop
- K211904 — Vinyl Glove
- K212067 — Deep Learning Image Reconstruction
- K212269 — Intelligent NR
- K212272 — Tempo Natural Tampon
- K203111 — Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
- K203112 — Disposable Medical Mask
- K211478 — Sterile Latex Surgical Gloves Powder Free
- K211479 — Blue Nitrile Examination Glove Powder Free
- K211512 — VISIONAIRE UK Patient Matched Cutting Guides
- K212021 — 6430 MyLabX75, 6430 MyLab XPro75
- K212283 — BioRoot Flow 0.5g, BioRoot Flow 2g
- K212604 — Symbia VA10A Family
- K212641 — StrataMR II Valves and Shunts
- K212742 — GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
- K202369 — RXS 1000
- K202885 — GlucoSure HT Plus Blood Glucose Monitoring System
- K203492 — Instrument tray, for semi-rigid ureteroscope
- K203649 — TruAbutment DS, TruBase
- K210085 — HealthCCSng
- K210118 — INFRARED BODY THERMOMETER (Model: YK-001)
- K210818 — TrueCare Biomedix Tamper Evident Cap
- K211227 — HTx Disposable Hysteroscope System
- K211276 — Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
- K212009 — Disposable Nitrile Gloves
- K212556 — mi-eye 3 needlescope with cannula, mi-tablet 3
- K212606 — BeamSite
- K212710 — GLOBAL UNITE Platform Shoulder System
- K193650 — LIAISON Ferritin
- K202396 — VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
- K210184 — Wilson Tech Disposable Medical Face Mask
- K210461 — End Cap
- K210586 — Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
- K211283 — Compressible Limb and Circulation Therapy System, Model POWER-Q2300
- K211305 — ANNE One
- K211389 — Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
- K211464 — Nitta M&T Safety Box
- K211474 — Kleiner KG2 System
- K211494 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K211738 — Rotarex Atherectomy System
- K212291 — PHOENIX
- K212678 — Viveve System, Viveve 2.0 System
- K201793 — EDEN Peek Cage
- K202540 — EliA Rib-P
- K202541 — EliA RNA Pol III
- K203455 — Disposable Medical Mask
- K210396 — Harmony Referral System
- K211270 — CIV-Clear cover
- K212214 — HandX
- K212412 — IRIS-XP
- K212685 — KONICAMINOLTA DI-X1
- K211296 — Surgical face mask
- K202056 — Kinepict Medical Imaging Tool 4.0
- K203785 — ClariSIGMAM
- K210093 — AccuFFRangio
- K210160 — AlertWatch:AC
- K210227 — Sterile syringe for single use with/without needle
- K210410 — s-Clean Pre-Milled Abutment Mini
- K210438 — Versana Premier
- K210625 — JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
- K211257 — EFAI PACS Picture Archiving and Communication System
- K211334 — Iovera System
- K211375 — Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter
- K211488 — LOGIQ E10
- K211828 — Aquilion Exceed LB
- K211856 — gammaCore Sapphire
- K212451 — Surgical Mask
- K212540 — Explorer TO System
- K201785 — EPIEN Dental Cleanser
- K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K210402 — Curiteva Sacroiliac Joint Fusion System
- K210509 — Rocket Platinum Cured Cathter
- K211242 — Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
- K211352 — Electronic Thermometer (XHF2001, XHF2002)
- K211824 — HERA W9, HERA W10 Diagnostic Ultrasound System
- K212246 — Exofin Precision Pen
- K212553 — DIGITAL RADIOGRAPHY CXDI-Pro, D1
- DEN200030 — FEops HEARTguide
- K203434 — BlueStar Rx
- K203555 — AmCAD-UT
- K210712 — Verifine Mechanical Safety Insulin Syringe
- K211127 — Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
- K211235 — CIRCUL8 Luxe DVT Prevention Device
- K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K211832 — Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
- K211867 — RayStation 11.0
- K211945 — V8 Diagnostic Ultrasound System
- K212058 — Longeviti ClearFit OTS Cranial Implants
- K212495 — Leva Pelvic Health System
Data sourced from openFDA. This site is unofficial and independent of the FDA.