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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
Tula Tube Delivery System (TDS)

Tusker Medical

Cleared 2026-07-31

Registered with
  • US (FDA)
Angled Screwdriver MED (M-SD090)

W&H Dentalwerk Burmoos

Cleared 2026-07-31

Registered with
  • US (FDA)
Hintermann Series H3 Total Ankle Replacement System

DT MedTech, LLC

Cleared 2026-07-31

Registered with
  • US (FDA)
Scoreflex NC Scoring PTCA Catheter

OrbusNeich Medical (Shenzhen) Co., Ltd.

Cleared 2026-07-31

Registered with
  • US (FDA)
NanoCeram Resin

3BFAB TEKNOLOJI ANONIM ŞIRKETI

Cleared 2026-07-31

Registered with
  • US (FDA)
neXus Ultrasonic Surgical Aspirator System

MISONIX LLC

Cleared 2026-07-30

Registered with
  • US (FDA)
TnR Cranial Implant

T&R Biofab Co., Ltd.

Cleared 2026-07-30

Registered with
  • US (FDA)
Arthrex Radial Head Replacement System

Arthrex, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
Handheld Ultrasound Scanner

IMGFAX CO., LTD.

Cleared 2026-07-30

Registered with
  • US (FDA)
LIFEPAK CR2 Automated External Defibrillator (AED)

Physio-Control, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
  • Canada (Health Canada)
PGDx elio tissue complete CDx

Personal Genome Diagnostics, Inc

Cleared 2026-07-30

Registered with
  • US (FDA)
dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

Philips Medical Systems Nederland BV

Cleared 2026-07-30

Registered with
  • US (FDA)
Motivista (CT-155)

Click Therapeutics, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

Suite 201, National Innovation Centre

Cleared 2026-07-30

Registered with
  • US (FDA)
SmartGuide Disposable Guides and Grids

Uc-Care , Ltd.

Cleared 2026-07-30

Registered with
  • US (FDA)
LOGIQ Focus

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-07-30

Registered with
  • US (FDA)
Genio® System 2.1

Nyxoah SA

Cleared 2026-07-30

Registered with
  • US (FDA)
SeptAlign (SPLN001)

Spirair, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
Obsidian® Press Over Zirconia

Prismatik Dentalcraft, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
cmAngio® V2.0

Curemetrix, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
SMARTVERTIGO™ Vestibular Assessment System

VertigoDx, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
Sync AV II Temporary Pacing Catheter

Swift Sync, Inc.

Cleared 2026-07-30

Registered with
  • US (FDA)
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

SALTER LABS ALSO TRADING AS AIRLIFE

Cleared 2026-07-30

Registered with
  • US (FDA)
AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down

Stryker Endoscopy

Cleared 2026-07-30

Registered with
  • US (FDA)
Cleerly Labs

Cleerly, Inc.

Cleared 2026-07-29

Registered with
  • US (FDA)
SPINEART Navigation Instrument System

Spineart

Cleared 2026-07-29

Registered with
  • US (FDA)
Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection

Contego Medical, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
NAMIC Dilator and Sheath

Medline Industries, Inc.

Cleared 2026-07-29

Registered with
  • US (FDA)
SSPC NXT Delivery Catheter

Centerpoint Systems

Cleared 2026-07-29

Registered with
  • US (FDA)
  • AU (TGA)
EINSPIRIS RESILIA Aortic Valve, Model 11500A; KONECT RESILIA Aortic Valved Conduit (AVC), Model 11060A

Edwards Lifesciences, LLC

Cleared 2026-07-29

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Emanate Tray

Emanate Biomedical

Cleared 2026-07-29

Registered with
  • US (FDA)
Profoject™ Dual-Safety Pen Needles

Cmt Health Pte., Ltd.

Cleared 2026-07-29

Registered with
  • US (FDA)
GORE® EXCLUDER® Conformable AAA Endoprosthesis

W. L. Gore and Associates, Inc.

Cleared 2026-07-29

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Cleerly Plaque

Cleerly, Inc.

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)
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)