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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
ICD INOGEN™ VR DF4 (D010); ICD INOGEN™ VR DF1/IS1 (D011); ICD INOGEN™ DR DF4/IS1 (D012); ICD INOGEN™ DR DF1/IS1 (D013);

Boston Scientific Corp

Cleared 2026-08-25

Registered with
  • US (FDA)
Report Studio

Beacon Biosignals, Inc.

Cleared 2026-08-25

Registered with
  • US (FDA)
Ceevra Reveal 4

Ceevra, Inc.

Cleared 2026-08-25

Registered with
  • US (FDA)
Defibtech Automated External Defibrillator (AED) Systems

Defibtech, LLC

Cleared 2026-08-25

Registered with
  • US (FDA)
Calcium Hydroxide Temporary Filling Material (KP-Cal)

Guilin Kevin Peter Technology Co Ltd

Cleared 2026-08-25

Registered with
  • US (FDA)
Promisemed X-Safety Pen Needle

Promisemed Hangzhou Meditech Co., Ltd.

Cleared 2026-08-25

Registered with
  • US (FDA)
PATHWAYANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Ventana Medical Systems, Inc.

Cleared 2026-08-25

Registered with
  • US (FDA)
VENTANA HER2 Dual ISH DNA Probe Cocktail

Ventana Medical Systems, Inc.

Cleared 2026-08-25

Registered with
  • US (FDA)
  • UK (MHRA)
Inno-Switch™ Laparoscopic Instruments

Taiwan Surgical Corporation

Cleared 2026-08-25

Registered with
  • US (FDA)
SOL-M Luer Lock Syringe with Exchangeable Needle Tray

Sol-Millennium Medical

Cleared 2026-08-25

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
MOMENTUM™ CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM™ CRT-D IS1 DF1 LV1 (G126); MOMENTUM™ X4 CRT-D IS1 DF1 IS4 (G128, G138

Boston Scientific Corp

Cleared 2026-08-25

Registered with
  • US (FDA)
iNOS intraoral biosensor

Achaemenid, LLC

Cleared 2026-08-25

Registered with
  • US (FDA)
SEISMIQ™ Intravascular Lithotripsy System

Bolt Medical, Inc.

Cleared 2026-08-24

Registered with
  • US (FDA)
OsteoCoil™ GT Active Compression System

Flower Orthopedics Corporation DBA Conventus Flower Orthoped

Cleared 2026-08-24

Registered with
  • US (FDA)
Guided Bone Regeneration System

DentalMaster(Xiamen) Medical Technology Co., Ltd.

Cleared 2026-08-24

Registered with
  • US (FDA)
BiWaze Clear System

Abmrc, LLC

Cleared 2026-08-24

Registered with
  • US (FDA)
  • EU (EUDAMED)
TiLink-L SI Joint Fusion System

SurGenTec, LLC

Cleared 2026-08-24

Registered with
  • US (FDA)
Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments

Biomet Orthopedics, Inc.

Cleared 2026-08-24

Registered with
  • US (FDA)
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)

Sonoscape Medical Corp.

Cleared 2026-08-24

Registered with
  • US (FDA)
BTL-699

Btl Industries, Ltd.

Cleared 2026-08-23

Registered with
  • US (FDA)
Stitch - Suture Wires and Tapes

GM Dos Reis Industria e Comercio Ltda.

Cleared 2026-08-22

Registered with
  • US (FDA)
Artix™ MT;Artix™ Thin-Walled Sheath

Inari Medical, Inc.

Cleared 2026-08-21

Registered with
  • US (FDA)
IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

Immunodiagnostics Systems Limited

Cleared 2026-08-21

Registered with
  • US (FDA)
Solo Scope Colonoscope System

Gi View , Ltd.

Cleared 2026-08-21

Registered with
  • US (FDA)
DS Core CBCT Anatomy

Dentsply Sirona

Cleared 2026-08-21

Registered with
  • US (FDA)
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Boston Scientific Corp

Cleared 2026-08-21

Registered with
  • US (FDA)
Avulux

Matap Ii, LLC

Cleared 2026-08-21

Registered with
  • US (FDA)
AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors

Apyx Medical Corporation

Cleared 2026-08-21

Registered with
  • US (FDA)
ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS)

Spectranetics Corp.

Cleared 2026-08-21

Registered with
  • US (FDA)
SynchroMed Infusion System, Ascenda Intrathecal Catheters

Medtronic, Inc

Cleared 2026-08-21

Registered with
  • US (FDA)
Disposable Warming Blanket

Hangzhou Tappa Medical Technology Co, Ltd

Cleared 2026-08-21

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Any-Zircos

Mediclus Co., Ltd.

Cleared 2026-08-21

Registered with
  • US (FDA)
ReneuRx™ (Neural Ice)

Brixton Biosciences

Cleared 2026-08-21

Registered with
  • US (FDA)
Eluvia Drug-Eluting Vascular Stent System

Boston Scientific Corp

Cleared 2026-08-21

Registered with
  • US (FDA)
Affera Integrated Mapping System

Medtronic, Inc

Cleared 2026-08-21

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
TheraSphere™ Y-90 Glass Microspheres System

Boston Scientific Corp

Cleared 2026-08-21

Registered with
  • US (FDA)
Activa Deep Brain Stimulation Therapy System

Medtronic, Inc

Cleared 2026-08-21

Registered with
  • US (FDA)
Pisces-SC Standalone Cervical Interbody System

Osseus Fusions Systems, LLC

Cleared 2026-08-21

Registered with
  • US (FDA)
EVOLUTION® AM BIOFOAM® Tibial System

Microport Orthopedics, Inc.

Cleared 2026-08-21

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

Medtronic Neuromodulation

Cleared 2026-08-21

Registered with
  • US (FDA)
uAngio AVIVA CX

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2026-08-21

Registered with
  • US (FDA)
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM

Boston Scientific Corp

Cleared 2026-08-21

Registered with
  • US (FDA)
Neuspera Sacral Neuromodulation (SNM) System

Neuspera Medical, Inc.

Cleared 2026-08-21

Registered with
  • US (FDA)
Electric wheelchair (D03)

Foshan Sowell Medical Technology Co., Ltd.

Cleared 2026-08-21

Registered with
  • US (FDA)
Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM

Zeus Scientific, Inc.

Cleared 2026-08-21

Registered with
  • US (FDA)
Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire.

Boston Scientific Corp

Cleared 2026-08-21

Registered with
  • US (FDA)
BoneMRI

MRIguidance B.V.

Cleared 2026-08-21

Registered with
  • US (FDA)
  • EU (EUDAMED)
Tempus ECG-PH

Tempus AI, Inc.

Cleared 2026-08-21

Registered with
  • US (FDA)
AVVIGO'+ Multi-Modality Guidance System

Boston Scientific Corp

Cleared 2026-08-21

Registered with
  • US (FDA)
Cimilre Dual Max

Cimilre Co., Ltd.

Cleared 2026-08-21

Registered with
  • US (FDA)