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Recently FDA-cleared medical devices

Every device we hold with a US FDA 510(k) clearance decided in the last 12 months, newest first. Each one links through to its full regulatory record.

3,716 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
CaRi-Heart

Caristo Diagnostics

Cleared 2026-07-28

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;

Samsung Medison Co., Ltd.

Cleared 2026-07-28

Registered with
  • US (FDA)
TruLift Expandable System

Life Spine, LLC

Cleared 2026-07-28

Registered with
  • US (FDA)
See-Mode Augmented Reporting Tool, Breast (SMART-B)

See-Mode Technologies Pte, Ltd.

Cleared 2026-07-28

Registered with
  • US (FDA)
ARCHIMEDES Biodegradable Stent (Medium)

Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)

Cleared 2026-07-27

Registered with
  • US (FDA)
ND Needle Guidance System

Accurate Access, LLC

Cleared 2026-07-27

Registered with
  • US (FDA)
Air Compression Massager (HY-1165)

XIAMEN HIGH TOP ELECTRONIC TECHNOLOGY CO., LTD.

Cleared 2026-07-27

Registered with
  • US (FDA)
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, Inc.

Cleared 2026-07-27

Registered with
  • US (FDA)
Powered Aventus Thrombectomy System™

Inquis Medical

Cleared 2026-07-27

Registered with
  • US (FDA)
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter

Medtronic, Ireland

Cleared 2026-07-27

Registered with
  • US (FDA)
Total Temporomandibular Joint Replacement System

Biomet Microfixation

Cleared 2026-07-27

Registered with
  • US (FDA)
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

Shockwave Medical., Inc.

Cleared 2026-07-27

Registered with
  • US (FDA)
FlexTract Deflectable-Rotational Dilator Sheath Set

Merit Medical Systems, Inc.

Cleared 2026-07-27

Registered with
  • US (FDA)
Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)

Plus EV Holdings, Inc. D/B/A Intimate Rose

Cleared 2026-07-27

Registered with
  • US (FDA)
Corsano CardioWatch 287-2 System

Corsano Health BV

Cleared 2026-07-26

Registered with
  • US (FDA)
CorVista System® with PCWP Add-On

Analytics For Life, Inc.

Cleared 2026-07-26

Registered with
  • US (FDA)
MONARCH™ Platform (MON-000008)

AURIS HEALTH INCORPORATED

Cleared 2026-07-25

Registered with
  • US (FDA)
METICULY Patient-specific CMF solution

Meticuly Co., Ltd.

Cleared 2026-07-25

Registered with
  • US (FDA)
Air Compression Massager (EP30B001 I)

Wavepulse (Xiamen) Healthcare Technology Co., Ltd.

Cleared 2026-07-24

Registered with
  • US (FDA)
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut

Hycor Biomedical, Inc.

Cleared 2026-07-24

Registered with
  • US (FDA)
Tiger 2 System

Zavation Medical Products, LLC

Cleared 2026-07-24

Registered with
  • US (FDA)
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2026-07-24

Registered with
  • US (FDA)
Temporary Keratoprosthesis (QuickSet TKP™)

EYEKON MEDICAL INC.

Cleared 2026-07-24

Registered with
  • US (FDA)
VS-370CF, VS-370CT

Vision Medical, Inc.

Cleared 2026-07-24

Registered with
  • US (FDA)
Ion-L Navigated Instruments

SurGenTec, LLC

Cleared 2026-07-24

Registered with
  • US (FDA)
PerfusiX-Imaging

LIMIS Development B.V.

Cleared 2026-07-24

Registered with
  • US (FDA)
  • EU (EUDAMED)
TheraSphere 360™ Y-90 Management Platform

Boston Scientific Corp

Cleared 2026-07-24

Registered with
  • US (FDA)
REMEDY POLY+PLUS SNAP FIT Acetabular Cup

Osteoremedies, LLC

Cleared 2026-07-24

Registered with
  • US (FDA)
5 Wavelength LED Facemask (TN2508)

Ismart Developments, Ltd.

Cleared 2026-07-24

Registered with
  • US (FDA)
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60

Thermo Fisher Scientific (Oxoid Ltd.)

Cleared 2026-07-24

Registered with
  • US (FDA)
Careflux H60;Careflux H70;Careflux V500

Fresenius Medical Care Renal Therapies Group, LLC

Cleared 2026-07-24

Registered with
  • US (FDA)
OBSIDIO™ Conformable Embolic

Boston Scientific Corp

Cleared 2026-07-24

Registered with
  • US (FDA)
VERAFEYE Imaging Catheter (VF-VIC-002)

Luma Vision Limited

Cleared 2026-07-24

Registered with
  • US (FDA)
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

Deka R&D Corp

Cleared 2026-07-24

Registered with
  • US (FDA)
Atellica CH Acetaminophen 2 (ACTM)

Siemens Healthcare Diagnostics

Cleared 2026-07-24

Registered with
  • US (FDA)
  • Canada (Health Canada)
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes

Cook Ireland, Ltd.

Cleared 2026-07-24

Registered with
  • US (FDA)
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

GE Medical Systems Information Technologies, Inc

Cleared 2026-07-24

Registered with
  • US (FDA)
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)

Medical Impact

Cleared 2026-07-24

Registered with
  • US (FDA)
QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)

MANTIZ Co., Ltd.

Cleared 2026-07-24

Registered with
  • US (FDA)
GEN 4 JOY Wheelchair

Free Wheelchair Mission

Cleared 2026-07-24

Registered with
  • US (FDA)
LumenCare Azure

Nucletron Corp.

Cleared 2026-07-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
FARADRIVE™ Steerable Sheath (M004PF21M402)

Boston Scientific Corp

Cleared 2026-07-24

Registered with
  • US (FDA)
SwiftMR

Airs Medical, Inc.

Cleared 2026-07-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T

Philips Medical Systems Nederland BV

Cleared 2026-07-24

Registered with
  • US (FDA)
Gelsyn-3

Ibsa Institut Biochimique SA

Cleared 2026-07-24

Registered with
  • US (FDA)
DIANA

ROPCA

Cleared 2026-07-24

Registered with
  • US (FDA)
  • EU (EUDAMED)
Accuro® 3S Needle Guide Kit

Rivanna Medical, LLC

Cleared 2026-07-24

Registered with
  • US (FDA)
Accuro 3S

Rivanna Medical, LLC

Cleared 2026-07-24

Registered with
  • US (FDA)
VELMENI for DENTISTS (V4D) 3D

Velmeni, Inc.

Cleared 2026-07-23

Registered with
  • US (FDA)
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)

Microlife Corp.

Cleared 2026-07-23

Registered with
  • US (FDA)