FDA 510(k) clearances — page 182
clearances on record, most recent first.
Clearances — page 182
18,101–18,200 of 176,479- K210390 — Apex 3D Total Ankle Replacement System
- DEN200006 — ClearUP Sinus Relief
- K191441 — Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
- K201285 — InMode Evolve System with the Tone Applicator
- K201420 — Republic Spine Dark Star Spinal System
- K201775 — NuVision ICE Catheter
- K202076 — Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
- K202078 — Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
- K202300 — Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
- K202658 — Vivid E80/ Vivid E90/ Vivid E95
- K202693 — NeoWave Pain Relief and Recovery System, Model# T16-2020
- K202838 — Andorate Universal Endoscope Tip Guard
- K202913 — NeuroCap (Model DEC22)
- K203054 — FlexSys
- K203146 — Akesis Galaxy RTi
- K203261 — Reprocessed Inquiry Steerable Diagnostic EP Catheter
- K203346 — OEC 3D
- K203425 — Surgical Mask
- K210309 — Cios Select (VA21) Flat Panel
- K210328 — SafeSept Blunt Needle
- K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
- K202137 — Disposable medical mask
- K203193 — BD Intraosseous Infusion System
- K203323 — Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
- K203387 — AlignRT Plus
- K210006 — MI DeTACH
- K210019 — Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
- K210225 — Surgical Face Mask
- K210307 — Cios Select (VA21) Image Intensifier
- K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
- K201674 — Cultura Collection and Transport System
- K202316 — Medical mask (Model: KKF-1A)
- K202518 — Promaxo MRI System
- K202879 — EOGas 4 Endo-SteriTest RRBI
- K203521 — FineCross M3
- K203576 — FORZA Ti Spacer System
- K203764 — TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
- K203807 — Ponto Bone Anchored Hearing System, MONO Surgery Kit
- K210043 — LOQTEQ Distal Lateral Femur Plate 4.5 System
- K210262 — Biograph Vision Quadra PET/CT System
- K210277 — 3M Attest Rapid Readout Biological Indicator, 1295
- K210280 — Geistlich Mucograft®, Geistlich Mucograft® Seal
- K210282 — WIRION Embolic Protection System
- K210293 — AtriClip LAA Exclusion System
- K210316 — Mars 1417X Wireless Digital Flat Panel Detector
- K201422 — Arisure Closed System Drug Transfer Device (CSTD)
- K201852 — Surgical Mask-Model Number: Ear Loop, Flat-Pleated
- K201965 — SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
- K202113 — Ceragem Automatic Thermal Massager, Model CGM-MB-1901
- K202166 — Senhance Surgical System
- K202214 — IFM Surgical Mask Model SM3
- K202356 — Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
- K202889 — Able Medical Devices Valkyrie Thoracic Fixation System
- K203086 — X-PLO2R
- K203394 — PleuraFlow System with FlowGlide
- K203617 — MaxFOV 2
- K203653 — MRI PPG Patient Cable
- K203755 — Shoulder System - TiNbN Coating
- K210010 — GMK Revision & Hinge Extension - TiNbN Coating
- K210266 — OverStitch Sx Endoscopic Suturing System
- K210314 — Mars1717X Wireless Digital Flat Panel Detector
- DEN200022 — Analytic for Hemodynamic Instability (AHI)
- K201533 — Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
- K201927 — Getinge GSS610N Series Steam Sterilizer
- K202037 — imani i2
- K202402 — Nitrile Examination Gloves (Blue, Violet Blue, White)
- K202678 — OMNI Surgical System
- K202743 — Med-Link Temp-pulse Oximeter
- K202776 — Fingertip pulse oximeter
- K203275 — Recon Support Catheter
- K203358 — Solitaire X Revascularization Device
- K210271 — NuVasive Modulus ALIF System
- K210550 — VALO Grand Corded and Accessory Lenses
- K201644 — QardioCore
- DEN190022 — Hominis Surgical System
- DEN200017 — Q-Collar
- K173738 — Archworx
- K200567 — ASI Plethysmogrpah Analyzer
- K201104 — AsoAligner
- K201316 — Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
- K201387 — Ultrafast, Ultrafast Plus, Ultrafast Lite
- K201967 — SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
- K201968 — SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
- K202045 — imani i1
- K202111 — Medical infrared forehead thermometer
- K202167 — Brite Tip Radianz Guiding Sheath
- K202549 — Solax Electric Scooter (Model: S202261B)
- K202702 — FLARE Single-Use Surgical Laser Fiber
- K202956 — Erisma LP Navigated Instruments
- K203020 — Spectral CT
- K203182 — SubtleMR
- K203439 — Disposable Vinyl Examination Gloves
- K203510 — IPL Hair removal
- K203651 — Cuptimize
- K203819 — T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System
- K210033 — Laser Treatment System, Model: NYX and Grace
- K210268 — LTJ Screws and Washer
- K210323 — Indigo Aspiration System - Lightning Aspiration Tubing
- K201142 — TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set
- K201436 — Vortek Single Loop Ureteral Stent
Data sourced from openFDA. This site is unofficial and independent of the FDA.