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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.

3,686 devices · when each source was last refreshed

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

Device
Cleerly Plaque

Cleerly, Inc.

Cleared 2026-07-29

Registered with
  • US (FDA)
PASCAL Precision implant system (20000IS and 20000ISM); PASCAL Precision guide sheath system (20000GS)

Edwards Lifesciences, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29);

Edwards Lifesciences, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
EDWARDS INTUITY Elite Valve, Model 8300AB

Edwards Lifesciences, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
Edwards SAPIEN M3 Dock (988DDS); Edwards 23F Guide Sheath (9880GS); Edwards SAPIEN M3 Crimper (9880CR); Edwards Commande

Edwards Lifesciences, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
CraniUS Plate

CraniUS, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
CPS Locator 3D Plus Delivery Catheter

Centerpoint Systems

Cleared 2026-07-29

Registered with
  • US (FDA)
Stone Clear (BWSC-LP9-02)

Sonomotion, Inc.

Cleared 2026-07-29

Registered with
  • US (FDA)
Suture Button Repair System

Skeletal Dynamics, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
ELISIO™-HX

NIPRO MEDICAL CORPORATION

Cleared 2026-07-28

Registered with
  • US (FDA)
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

Datex-Ohmeda, Inc

Cleared 2026-07-28

Registered with
  • US (FDA)
Revi System

Bluewind Medical , Ltd.

Cleared 2026-07-28

Registered with
  • US (FDA)
CARBOMEDICS PROSTHETIC HEART VALVE, CARBOMEDICS® SUPRA-ANNULAR PROSTHETIC HEART VALVE, OPTIFORM® PROSTHETIC MITRAL HEART

Corcym Srl

Cleared 2026-07-28

Registered with
  • US (FDA)
  • AU (TGA)
SURGICELTM POWDER Absorbable Hemostatic Powder

ETHICON LLC

Cleared 2026-07-28

Registered with
  • US (FDA)
Xpert Ankle

Newclip Technics S.A.S

Cleared 2026-07-28

Registered with
  • US (FDA)
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Hartalega NGC Sdn. Bhd.

Cleared 2026-07-28

Registered with
  • US (FDA)
uMI Panvivo (uMI Panvivo M)

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2026-07-28

Registered with
  • US (FDA)
IsoPSA Assay

Cleveland Diagnostics, Inc.

Cleared 2026-07-28

Registered with
  • US (FDA)
Healon PRO, Healon GV PRO and Healon5 PRO Ophthalmic Viscosurgical Devices (OVD)

Johnson&Johnson Surgical Vision Inc

Cleared 2026-07-28

Registered with
  • US (FDA)
BodyTom Elite (NL4000)

NeuroLogica Corp., a Samsung Company

Cleared 2026-07-28

Registered with
  • US (FDA)
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)
Dorsal Root Ganglion (DRG) IPG

Abbott Medical

Cleared 2026-07-26

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)
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)
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)

Olympus Surgical Technologies America

Cleared 2026-07-24

Registered with
  • US (FDA)