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.

3,400 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
ENTire IRE System Entire Medical , Ltd. Cleared 2026-05-29 Registered with US (FDA)	Entire Medical , Ltd.	2026-05-29	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)
POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREEZE Cryoablation System Console Boston Scientific Corp Cleared 2026-05-29 Registered with US (FDA)	Boston Scientific Corp	2026-05-29	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)
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) Philips Medizin Systeme Boblingen GmbH Cleared 2026-05-29 Registered with US (FDA)	Philips Medizin Systeme Boblingen GmbH	2026-05-29	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)
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus INTEROJO INC. Cleared 2026-05-29 Registered with US (FDA)	INTEROJO INC.	2026-05-29	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)
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) ANKER INNOVATIONS LIMITED Cleared 2026-05-29 Registered with US (FDA)	ANKER INNOVATIONS LIMITED	2026-05-29	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)
Navigated LLIF Impactable Tracker Tyber Medical, LLC Cleared 2026-05-29 Registered with US (FDA)	Tyber Medical, LLC	2026-05-29	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)
LUNE™ PureHygiene Enamel Pure Cleared 2026-05-29 Registered with US (FDA)	Enamel Pure	2026-05-29	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)
Exceed™ Biplanar Expandable Interbody System Spine Wave, Inc. Cleared 2026-05-29 Registered with US (FDA)	Spine Wave, Inc.	2026-05-29	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)
Nexus DRF Digital X-ray Imaging System Varex Imaging Corporation Cleared 2026-05-29 Registered with US (FDA)	Varex Imaging Corporation	2026-05-29	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)
GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) Cosmo Artificial Intelligence - Ai, Ltd. Cleared 2026-05-29 Registered with US (FDA)	Cosmo Artificial Intelligence - Ai, Ltd.	2026-05-29	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)
Xpert PFP Newclip Technics S.A.S Cleared 2026-05-29 Registered with US (FDA)	Newclip Technics S.A.S	2026-05-29	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)
CoSense ETCO Monitor Capnia, Inc. Cleared 2026-05-29 Registered with US (FDA) Canada (Health Canada)	Capnia, Inc.	2026-05-29	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T Biotronik, GmbH & Co. Cleared 2026-05-28 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Biotronik, GmbH & Co.	2026-05-28	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Ulike Clear Zero (YC10 BU) Guangxi Ulike Medical Technology Co., Ltd. Cleared 2026-05-28 Registered with US (FDA)	Guangxi Ulike Medical Technology Co., Ltd.	2026-05-28	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)
TriClip Delivery System Abbott Medical Cleared 2026-05-28 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Trexon™ Monofilament Synthetic Absorbable Suture Medtronic, Inc Cleared 2026-05-28 Registered with US (FDA)	Medtronic, Inc	2026-05-28	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)
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System Alcon Research, Ltd. Cleared 2026-05-28 Registered with US (FDA)	Alcon Research, Ltd.	2026-05-28	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)
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N Bioptimal International PTE LTD Cleared 2026-05-28 Registered with US (FDA)	Bioptimal International PTE LTD	2026-05-28	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)
Helio Kids; Apex P Motion Composites Cleared 2026-05-28 Registered with US (FDA)	Motion Composites	2026-05-28	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)
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) Balloon Catheter Medtronic, Inc Cleared 2026-05-28 Registered with US (FDA)	Medtronic, Inc	2026-05-28	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)
Deep Brain Stimulation (DBS) Systems Boston Scientific Corp Cleared 2026-05-28 Registered with US (FDA)	Boston Scientific Corp	2026-05-28	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)
BD BACTEC FXI Culture System Bd Diagnostic Systems Cleared 2026-05-28 Registered with US (FDA)	Bd Diagnostic Systems	2026-05-28	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)
AmplatzerTM PFO Occluder; AmplatzerTM Talisman™ PFO Occluder Abbott Medical Cleared 2026-05-28 Registered with US (FDA)	Abbott Medical	2026-05-28	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)
Inspire Model 4063 Leads; Inspire Model 4340 Leads Inspire Medical Systems Cleared 2026-05-28 Registered with US (FDA)	Inspire Medical Systems	2026-05-28	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)
BMD Titanium Spinal Fusion System Global Biomedica sro Cleared 2026-05-28 Registered with US (FDA)	Global Biomedica sro	2026-05-28	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)
Dukal Crepe Paper Sterilization Wrap DUKAL LLC Cleared 2026-05-28 Registered with US (FDA)	DUKAL LLC	2026-05-28	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)
AmplatzerTM Muscular VSD Occluder Abbott Medical Cleared 2026-05-28 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Bellalun 2D (VDMS-1000S) Vieworks Co., Ltd. Cleared 2026-05-28 Registered with US (FDA)	Vieworks Co., Ltd.	2026-05-28	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)
Arthrex Bioabsorbable PushLock Suture Anchors Arthrex, Inc. Cleared 2026-05-28 Registered with US (FDA)	Arthrex, Inc.	2026-05-28	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)
780 nm SPY Portable Handheld Imaging (SPY-PHI) System Stryker Endoscopy Cleared 2026-05-28 Registered with US (FDA)	Stryker Endoscopy	2026-05-28	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)
MI Cancer Seek Caris Life Sciences Cleared 2026-05-28 Registered with US (FDA)	Caris Life Sciences	2026-05-28	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 Ablation System Medtronic, Inc Cleared 2026-05-28 Registered with US (FDA) UK (MHRA)	Medtronic, Inc	2026-05-28	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
xT CDx Tempus Labs, Inc. Cleared 2026-05-28 Registered with US (FDA)	Tempus Labs, Inc.	2026-05-28	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)
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System Alcon Research, Ltd. Cleared 2026-05-28 Registered with US (FDA)	Alcon Research, Ltd.	2026-05-28	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)
Woven EndoBridge (WEB) Aneurysm Embolization System Microvention, Inc. Cleared 2026-05-28 Registered with US (FDA)	Microvention, Inc.	2026-05-28	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)
AmplatzerTM Duct Occluder Abbott Medical Cleared 2026-05-28 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Spinal Cord Stimulation (SCS) Boston Scientific Corp Cleared 2026-05-28 Registered with US (FDA)	Boston Scientific Corp	2026-05-28	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)
Abbott RealTime IDH1 Abbott Molecular, Inc. Cleared 2026-05-28 Registered with US (FDA)	Abbott Molecular, Inc.	2026-05-28	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)
Abbott RealTime IDH2 Abbott Molecular, Inc. Cleared 2026-05-28 Registered with US (FDA)	Abbott Molecular, Inc.	2026-05-28	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)
ANDI 2.2 Imeka Solutions, Inc. Cleared 2026-05-28 Registered with US (FDA)	Imeka Solutions, Inc.	2026-05-28	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 Endoscopic Distal Attachments Yangzhou Fartley Medical Instrument Technology Co,., Ltd. Cleared 2026-05-28 Registered with US (FDA)	Yangzhou Fartley Medical Instrument Technology Co,., Ltd.	2026-05-28	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)
MitraClip Delivery Systems Abbott Medical Cleared 2026-05-28 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
AmplatzerTM Amulet Left Atrial Appendage Occluder Abbott Medical Cleared 2026-05-28 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
STIMPOD NMS460 Nerve Stimulator Algiamed Technologies USA, Inc. Cleared 2026-05-28 Registered with US (FDA)	Algiamed Technologies USA, Inc.	2026-05-28	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 Persona Personalized Knee System Zimmer Inc Cleared 2026-05-28 Registered with US (FDA)	Zimmer Inc	2026-05-28	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)
SelectSecure Lead Model 3830 Medtronic Cardiac Rhythm Disease Management Cleared 2026-05-28 Registered with US (FDA)	Medtronic Cardiac Rhythm Disease Management	2026-05-28	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)
AmplatzerTM Septal Occluder; AmplatzerTM Multifenestrated Septal Occluder - Cribriform Abbott Medical Cleared 2026-05-28 Registered with US (FDA) AU (TGA)	Abbott Medical	2026-05-28	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection Contego Medical, LLC Cleared 2026-05-27 Registered with US (FDA)	Contego Medical, LLC	2026-05-27	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)
Synapse Lung Nodule AI FUJIFILM Corporation Cleared 2026-05-27 Registered with US (FDA)	FUJIFILM Corporation	2026-05-27	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)
Helion Viewer Suite Videomed Srl ( a Baxter Healthcare Corp company) Cleared 2026-05-27 Registered with US (FDA)	Videomed Srl ( a Baxter Healthcare Corp company)	2026-05-27	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)