HaRi
Start Free→

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
xvision Spine System

Augmedics, Ltd.

Cleared 2026-07-31

Registered with
  • US (FDA)
MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure

Siemens Healthineers AG

Cleared 2026-07-31

Registered with
  • US (FDA)
LightStim for Wrinkles (1984); LightStim for Acne (2038)

Led Intellectual Properties, LLC

Cleared 2026-07-31

Registered with
  • US (FDA)
UniPearls® Embolic Microspheres

Suzhou Haowei Medical Technology Co., Ltd.

Cleared 2026-07-31

Registered with
  • US (FDA)
0909FCE, 0909FCE-HS

Rayence Co., Ltd.

Cleared 2026-07-31

Registered with
  • US (FDA)
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)

Medtronic, Inc

Cleared 2026-07-31

Registered with
  • US (FDA)
Vertiwedge® Intraosseous System

Foundation Surgical Group, Inc.

Cleared 2026-07-31

Registered with
  • US (FDA)
Interwedge® Standalone Lateral

Foundation Surgical Group, Inc.

Cleared 2026-07-31

Registered with
  • US (FDA)
da Vinci Surgical System, Model IS5000

Intuitive Surgical, Inc.

Cleared 2026-07-31

Registered with
  • US (FDA)
VitalFlow Set with Balance Biosurface

Medtronic, Inc

Cleared 2026-07-31

Registered with
  • US (FDA)
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Medtronic, Inc

Cleared 2026-07-31

Registered with
  • US (FDA)
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)

OrthAlign, Inc

Cleared 2026-07-31

Registered with
  • US (FDA)
ZSAlign Cervical Interbody System

Zsfab, Inc.

Cleared 2026-07-31

Registered with
  • US (FDA)
MAGiC Ablation Catheter

Stereotaxis, Inc.

Cleared 2026-07-31

Registered with
  • US (FDA)
Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)

Shanghai Hulu Devices Co., Ltd.

Cleared 2026-07-31

Registered with
  • US (FDA)
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)
LifeVest Wearable Defibrillator

Zoll Manufacturing Corporation

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)
Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20; 9600TFX23; 9600TFX26; 9600TFX29)

Edwards Lifesciences, LLC

Cleared 2026-07-29

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