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.

3,665 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
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) F Care Systems USA, LLC Cleared 2026-06-02 Registered with US (FDA)	F Care Systems USA, LLC	2026-06-02	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)
Hemospray Endoscopic Hemostat (HEMO-[X]) Wilson-Cook Medical, Inc. Cleared 2026-06-02 Registered with US (FDA)	Wilson-Cook Medical, Inc.	2026-06-02	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)
DB 4000 High Impact Denture Base Carbon, Inc. Cleared 2026-06-02 Registered with US (FDA)	Carbon, Inc.	2026-06-02	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)
Cube 4D Navigation System, VirtuEye Pro Fiagon GmbH Cleared 2026-06-02 Registered with US (FDA)	Fiagon GmbH	2026-06-02	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)
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) FindAir Sp. z o.o. Cleared 2026-06-02 Registered with US (FDA)	FindAir Sp. z o.o.	2026-06-02	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)
Harmony™ Transcatheter Pulmonary Valve System Medtronic, Inc Cleared 2026-06-01 Registered with US (FDA) AU (TGA)	Medtronic, Inc	2026-06-01	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
VisionAir Enhanced Stock Stent VisionAir Solutions Cleared 2026-06-01 Registered with US (FDA)	VisionAir Solutions	2026-06-01	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)
CorDx Tyfast COVID-19 Ag Rapid Test Rx CorDx, Inc. Cleared 2026-06-01 Registered with US (FDA)	CorDx, Inc.	2026-06-01	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)
VI°Port™ Liver Preservation System TRAFEROX TECHNOLOGIES INC. Cleared 2026-06-01 Registered with US (FDA)	TRAFEROX TECHNOLOGIES INC.	2026-06-01	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)
CardioMEMS™ HF System Abbott Medical Cleared 2026-06-01 Registered with US (FDA)	Abbott Medical	2026-06-01	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)
CoLink® & CoLag® Non-Sterile Screws In2bones USA, LLC Cleared 2026-05-30 Registered with US (FDA)	In2bones USA, LLC	2026-05-30	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)
Oxygen Concentrator (OX-5A, OX-5C) Oxytek Medical Technology Co, Ltd Cleared 2026-05-29 Registered with US (FDA)	Oxytek Medical Technology Co, 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)
ZEUS Platform (FG0501US) iRhythm Technologies, Inc. Cleared 2026-05-29 Registered with US (FDA)	iRhythm Technologies, 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)
HistoSonics® Planning Tool HistoSonics, Inc. Cleared 2026-05-29 Registered with US (FDA)	HistoSonics, 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)
Air Optix Aqua for Astigmatism / Aqua Multifocal / plus Hydraglyde / plus Hydraglyde Multifocal / plus Hydraglyde for As Alcon Laboratories Cleared 2026-05-29 Registered with US (FDA)	Alcon Laboratories	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)
TOPS™ System Premia Spine, Ltd. Cleared 2026-05-29 Registered with US (FDA) AU (TGA)	Premia Spine, Ltd.	2026-05-29	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
M12 Telemetry System Global Instrumentation, LLC Cleared 2026-05-29 Registered with US (FDA)	Global Instrumentation, 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)
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit C.R. Bard, Inc. Cleared 2026-05-29 Registered with US (FDA)	C.R. Bard, 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)
Peak Flow Meter (PF-10(BR-PEF231)) Shenzhen Bi-Rich Medical Devices Co Ltd Cleared 2026-05-29 Registered with US (FDA)	Shenzhen Bi-Rich Medical Devices Co 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)
OrthoGrid Hip AI® 4.0 Orthogrid Systems, Inc. Cleared 2026-05-29 Registered with US (FDA)	Orthogrid Systems, 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)
Cryo Sport 2.0 (AVA 501) Avanutri Equipamentos DE Saúde Cleared 2026-05-29 Registered with US (FDA)	Avanutri Equipamentos DE Saúde	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)
LASEmaR 1500 Eufoton Srl Cleared 2026-05-29 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Eufoton Srl	2026-05-29	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Injection Needle Mirco-Tech (Nanjing) Co., Ltd. Cleared 2026-05-29 Registered with US (FDA)	Mirco-Tech (Nanjing) Co., 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)
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)
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)
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 Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty 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)
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)
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)
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)
xT CDx Tempus AI, Inc. Cleared 2026-05-28 Registered with US (FDA)	Tempus AI, 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)