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.

3,659 devices · when each source was last refreshed

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

Device	Manufacturer	Cleared	US	UK	CA	AU	EU
Inno-Switch™ Laparoscopic Instruments Taiwan Surgical Corporation Cleared 2026-08-25 Registered with US (FDA)	Taiwan Surgical Corporation	2026-08-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
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)	Sol-Millennium Medical	2026-08-25	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with 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)	Boston Scientific Corp	2026-08-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
iNOS intraoral biosensor Achaemenid, LLC Cleared 2026-08-25 Registered with US (FDA)	Achaemenid, LLC	2026-08-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
SEISMIQ™ Intravascular Lithotripsy System Bolt Medical, Inc. Cleared 2026-08-24 Registered with US (FDA)	Bolt Medical, Inc.	2026-08-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
OsteoCoil™ GT Active Compression System Flower Orthopedics Corporation DBA Conventus Flower Orthoped Cleared 2026-08-24 Registered with US (FDA)	Flower Orthopedics Corporation DBA Conventus Flower Orthoped	2026-08-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Guided Bone Regeneration System DentalMaster(Xiamen) Medical Technology Co., Ltd. Cleared 2026-08-24 Registered with US (FDA)	DentalMaster(Xiamen) Medical Technology Co., Ltd.	2026-08-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BiWaze Clear System Abmrc, LLC Cleared 2026-08-24 Registered with US (FDA) EU (EUDAMED)	Abmrc, LLC	2026-08-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
TiLink-L SI Joint Fusion System SurGenTec, LLC Cleared 2026-08-24 Registered with US (FDA)	SurGenTec, LLC	2026-08-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments Biomet Orthopedics, Inc. Cleared 2026-08-24 Registered with US (FDA)	Biomet Orthopedics, Inc.	2026-08-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
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)	Sonoscape Medical Corp.	2026-08-24	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BTL-699 Btl Industries, Ltd. Cleared 2026-08-23 Registered with US (FDA)	Btl Industries, Ltd.	2026-08-23	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Stitch - Suture Wires and Tapes GM Dos Reis Industria e Comercio Ltda. Cleared 2026-08-22 Registered with US (FDA)	GM Dos Reis Industria e Comercio Ltda.	2026-08-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Artix™ MT;Artix™ Thin-Walled Sheath Inari Medical, Inc. Cleared 2026-08-21 Registered with US (FDA)	Inari Medical, Inc.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
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)	Immunodiagnostics Systems Limited	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Solo Scope Colonoscope System Gi View , Ltd. Cleared 2026-08-21 Registered with US (FDA)	Gi View , Ltd.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
DS Core CBCT Anatomy Dentsply Sirona Cleared 2026-08-21 Registered with US (FDA)	Dentsply Sirona	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM Boston Scientific Corp Cleared 2026-08-21 Registered with US (FDA)	Boston Scientific Corp	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Avulux Matap Ii, LLC Cleared 2026-08-21 Registered with US (FDA)	Matap Ii, LLC	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors Apyx Medical Corporation Cleared 2026-08-21 Registered with US (FDA)	Apyx Medical Corporation	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) Spectranetics Corp. Cleared 2026-08-21 Registered with US (FDA)	Spectranetics Corp.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
SynchroMed Infusion System, Ascenda Intrathecal Catheters Medtronic, Inc Cleared 2026-08-21 Registered with US (FDA)	Medtronic, Inc	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Any-Zircos Mediclus Co., Ltd. Cleared 2026-08-21 Registered with US (FDA)	Mediclus Co., Ltd.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ReneuRx™ (Neural Ice) Brixton Biosciences Cleared 2026-08-21 Registered with US (FDA)	Brixton Biosciences	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Eluvia Drug-Eluting Vascular Stent System Boston Scientific Corp Cleared 2026-08-21 Registered with US (FDA)	Boston Scientific Corp	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Affera Integrated Mapping System Medtronic, Inc Cleared 2026-08-21 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Medtronic, Inc	2026-08-21	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
TheraSphere™ Y-90 Glass Microspheres System Boston Scientific Corp Cleared 2026-08-21 Registered with US (FDA)	Boston Scientific Corp	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Pisces-SC Standalone Cervical Interbody System Osseus Fusions Systems, LLC Cleared 2026-08-21 Registered with US (FDA)	Osseus Fusions Systems, LLC	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
EVOLUTION® AM BIOFOAM® Tibial System Microport Orthopedics, Inc. Cleared 2026-08-21 Registered with US (FDA)	Microport Orthopedics, Inc.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
uAngio AVIVA CX Shanghai United Imaging Healthcare Co., Ltd. Cleared 2026-08-21 Registered with US (FDA)	Shanghai United Imaging Healthcare Co., Ltd.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM Boston Scientific Corp Cleared 2026-08-21 Registered with US (FDA)	Boston Scientific Corp	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Neuspera Sacral Neuromodulation (SNM) System Neuspera Medical, Inc. Cleared 2026-08-21 Registered with US (FDA)	Neuspera Medical, Inc.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Electric wheelchair (D03) Foshan Sowell Medical Technology Co., Ltd. Cleared 2026-08-21 Registered with US (FDA)	Foshan Sowell Medical Technology Co., Ltd.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM Zeus Scientific, Inc. Cleared 2026-08-21 Registered with US (FDA)	Zeus Scientific, Inc.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire. Boston Scientific Corp Cleared 2026-08-21 Registered with US (FDA)	Boston Scientific Corp	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BoneMRI MRIguidance B.V. Cleared 2026-08-21 Registered with US (FDA) EU (EUDAMED)	MRIguidance B.V.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Tempus ECG-PH Tempus AI, Inc. Cleared 2026-08-21 Registered with US (FDA)	Tempus AI, Inc.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
AVVIGO'+ Multi-Modality Guidance System Boston Scientific Corp Cleared 2026-08-21 Registered with US (FDA)	Boston Scientific Corp	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Cimilre Dual Max Cimilre Co., Ltd. Cleared 2026-08-21 Registered with US (FDA)	Cimilre Co., Ltd.	2026-08-21	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Disposable Warming Blanket Hangzhou Tappa Medical Technology Co, Ltd Cleared 2026-08-21 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Hangzhou Tappa Medical Technology Co, Ltd	2026-08-21	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
MIRA Surgical System Virtual Incision Cleared 2026-08-20 Registered with US (FDA)	Virtual Incision	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Infinity® Acute Care System (IACS) – VG8.1 Draeger Medical Systems, Inc. Cleared 2026-08-20 Registered with US (FDA)	Draeger Medical Systems, Inc.	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Valence InVent Xtend™ (CVG-4101-VXA) Convergence Medical Sciences , Ltd. Cleared 2026-08-20 Registered with US (FDA)	Convergence Medical Sciences , Ltd.	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Globe® Catheter and Globe® Pulsed Field System Kardium, Inc. Cleared 2026-08-20 Registered with US (FDA)	Kardium, Inc.	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Spiration Valve System Deployment Catheter and Loader Gyrus Acmi, Inc. Cleared 2026-08-20 Registered with US (FDA)	Gyrus Acmi, Inc.	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
SCALA® TL Spineart Cleared 2026-08-20 Registered with US (FDA)	Spineart	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
CPETWise Platform Medibyt , Ltd. Cleared 2026-08-20 Registered with US (FDA)	Medibyt , Ltd.	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HardyDisk AST Tebipenem 10µg (TBP10) Hardy Diagnostics Cleared 2026-08-20 Registered with US (FDA)	Hardy Diagnostics	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Qoramatic Automated Stool Management Cm Technologies, Inc. Cleared 2026-08-20 Registered with US (FDA)	Cm Technologies, Inc.	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Remex Spine Surgery Navigation - Universal Instruments Remex Medical Corporation Cleared 2026-08-20 Registered with US (FDA)	Remex Medical Corporation	2026-08-20	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)