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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.

3,670 devices · when each source was last refreshed

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

Device
Activa Deep Brain Stimulation Therapy System

Medtronic, Inc

Cleared 2026-09-24

Registered with
  • US (FDA)
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

inomed Medizintechnik GmbH

Cleared 2026-09-24

Registered with
  • US (FDA)
Perclose ProStyle Suture-Mediated Closure and Repair System

Abbott Vascular, Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
  • UK (MHRA)
OPTIMIZER® Smart Mini System

Impulse Dynamics (Usa), Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™

Medtronic Neuromodulation

Cleared 2026-09-24

Registered with
  • US (FDA)
Disposable Belts for Polysomnography (CNSAC)

CNSAC MedShop GmbH

Cleared 2026-09-24

Registered with
  • US (FDA)
Creep Pressure Test Update for the Nexgen LPS Bearing Knee

Zimmer Inc

Cleared 2026-09-24

Registered with
  • US (FDA)
Arthrex Spine Compression FT Screw

Arthrex, Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
STA® - Liquid Anti-Xa

Diagnostica Stago

Cleared 2026-09-24

Registered with
  • US (FDA)
  • UK (MHRA)
MPa Max adhesive

DEN-MAT HOLDINGS, LLC (DBA CLINICIAN'S CHOICE) [CLINICIAN'S CHOICE,

Cleared 2026-09-24

Registered with
  • US (FDA)
Pediatric Nailing Platform Femur

Orthopediatrics, LLC

Cleared 2026-09-24

Registered with
  • US (FDA)
C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric

Rayner Intraocular Lenses , Ltd.

Cleared 2026-09-24

Registered with
  • US (FDA)
LIFEPAK 15 MONITOR/DEFIBRILLATOR

Physio-Control, Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
  • Canada (Health Canada)
Synergy Ablation System

AtriCure, Inc.

Cleared 2026-09-24

Registered with
  • US (FDA)
QIAstat-Dx BCID GN Plus AMR Panel

QIAGEN GmbH

Cleared 2026-09-24

Registered with
  • US (FDA)
  • EU (EUDAMED)
ProVee System for BPH

Proverum Limited

Cleared 2026-09-24

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

Abbott Medical

Cleared 2026-09-23

Registered with
  • US (FDA)
Deep Brain Stimulation (DBS) IPG

Abbott Medical

Cleared 2026-09-23

Registered with
  • US (FDA)
Hair Growth Comb (X-GC01)

Guangdong Ashmore Health Technology Co., Ltd.

Cleared 2026-09-23

Registered with
  • US (FDA)
Electric wheelchair (GP100)

SUZHOU GREEN PINE MEDICAL CO., LTD

Cleared 2026-09-23

Registered with
  • US (FDA)
Anti-HCV Next

Abbott Laboratories

Cleared 2026-09-23

Registered with
  • US (FDA)
ProRib Fixation System

Costa Surgical, Inc.

Cleared 2026-09-23

Registered with
  • US (FDA)
Single-use Flexible Bronchoscope

Hunan Vathin Medical Instrument Co., Ltd.

Cleared 2026-09-23

Registered with
  • US (FDA)
G7® Acetabular System

Zimmer Biomet

Cleared 2026-09-23

Registered with
  • US (FDA)
Etema™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Abbott Medical

Cleared 2026-09-23

Registered with
  • US (FDA)
Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20; 9600TFX23; 9600TFX26; 9600TFX29)

Edwards Lifesciences, LLC

Cleared 2026-09-23

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants

Intersect Ent.

Cleared 2026-09-23

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

Edwards Lifesciences, LLC

Cleared 2026-09-23

Registered with
  • US (FDA)
Everslide

Special Situations, LLC

Cleared 2026-09-23

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

Edwards Lifesciences, LLC

Cleared 2026-09-23

Registered with
  • US (FDA)
Portable Oxygen Concentrator (OX-1A-E, OX-1B)

Oxytek Medical Technology Co, Ltd

Cleared 2026-09-23

Registered with
  • US (FDA)
DynaNail Helix® Fixation System

MedShape, Inc.

Cleared 2026-09-23

Registered with
  • US (FDA)
HeartWare™ Ventricular Assist System or HeartWare™ System

Medtronic, Inc

Cleared 2026-09-23

Registered with
  • US (FDA)
Cemented Plus Abutment

Unidental Co., Ltd.

Cleared 2026-09-23

Registered with
  • US (FDA)
VIRTUE QA

Pronova Solutions, LLC

Cleared 2026-09-23

Registered with
  • US (FDA)
SABER-C System

Elevation Spine

Cleared 2026-09-23

Registered with
  • US (FDA)
iFuse Granite Onyx™ Implant System

Si-Bone, Inc.

Cleared 2026-09-23

Registered with
  • US (FDA)
Allurion Gastric Balloon System

ALLURION TECHNOLOGIES, INC.

Cleared 2026-09-23

Registered with
  • US (FDA)
  • EU (EUDAMED)
DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece

SETAGAYA SEIKI Co., Ltd.

Cleared 2026-09-23

Registered with
  • US (FDA)
Liquick X-treme, Liquick X-treme Plus

Teleflex Medical Sdn Bhd

Cleared 2026-09-23

Registered with
  • US (FDA)
Syneris PACS v.1.0.1.0

Syneris

Cleared 2026-09-23

Registered with
  • US (FDA)
BTL-299-F

Btl Industries, Ltd.

Cleared 2026-09-23

Registered with
  • US (FDA)
IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA

Siemens Medical Solutions Diagnostics

Cleared 2026-09-22

Registered with
  • US (FDA)
Actolind® (06.3637. Actolind® Gel Plus)

ACTO

Cleared 2026-09-22

Registered with
  • US (FDA)
Instant-View® hCG Combo II Cassette Test

ALFA SCIENTIFIC DESIGNS, INC.

Cleared 2026-09-22

Registered with
  • US (FDA)
BioFire Respiratory Panel 2.1 (RP2.1)

Biofire Diagnostics, Inc.

Cleared 2026-09-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
BoneXpert

Visiana

Cleared 2026-09-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai

Boston Scientific Corp

Cleared 2026-09-22

Registered with
  • US (FDA)
BodyTom 64 (NL4100); OmniTom Elite (NL5000)

SAMSUNG HME AMERICA, INC., DBA NEUROLOGICA CORP.

Cleared 2026-09-22

Registered with
  • US (FDA)
HipStudio Analysis

Replasia BV

Cleared 2026-09-22

Registered with
  • US (FDA)