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
BTL-899TT Btl Industries, Ltd. Cleared 2026-06-12 Registered with US (FDA)	Btl Industries, Ltd.	2026-06-12	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)
Virtus Somnomed, Ltd. Cleared 2026-06-12 Registered with US (FDA)	Somnomed, Ltd.	2026-06-12	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)
Fast PCR Mini Respiratory Panel Autonomous Medical Devices Incorporated Cleared 2026-06-12 Registered with US (FDA)	Autonomous Medical Devices Incorporated	2026-06-12	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)
Exalta Proximal Tibia Plating System Tyber Medical, LLC Cleared 2026-06-12 Registered with US (FDA)	Tyber Medical, LLC	2026-06-12	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)
HARBOR Occlusion Device Nuvascular, Inc. Cleared 2026-06-12 Registered with US (FDA)	Nuvascular, Inc.	2026-06-12	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)
Intense Pulsed Light Therapy Device Sanhe Lefis Electronics Co., Ltd. Cleared 2026-06-12 Registered with US (FDA)	Sanhe Lefis Electronics Co., Ltd.	2026-06-12	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)
Barbed PDO Suture Sutura Medical Technology, Inc. Cleared 2026-06-12 Registered with US (FDA)	Sutura Medical Technology, Inc.	2026-06-12	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)
ADRx™ Admixture Device Epic Medical Pte. , Ltd. Cleared 2026-06-12 Registered with US (FDA)	Epic Medical Pte. , Ltd.	2026-06-12	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 Blood Lancet (Soft) Sterilance Medical(Suzhou), Inc. Cleared 2026-06-12 Registered with US (FDA)	Sterilance Medical(Suzhou), Inc.	2026-06-12	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)
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) PR Personal Care Laboratories Cleared 2026-06-11 Registered with US (FDA)	PR Personal Care Laboratories	2026-06-11	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)
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical, Inc. Cleared 2026-06-11 Registered with US (FDA)	Mighty Oak Medical, Inc.	2026-06-11	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)
Snorbliss® Anti-Snoring Device Endeavor Commerce, LLC Cleared 2026-06-11 Registered with US (FDA)	Endeavor Commerce, LLC	2026-06-11	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)
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) Shenzhen Magnet Technology Co., Ltd. Cleared 2026-06-11 Registered with US (FDA)	Shenzhen Magnet Technology Co., Ltd.	2026-06-11	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)
UNEEG EpiSight System UNEEG medical AS Cleared 2026-06-11 Registered with US (FDA)	UNEEG medical AS	2026-06-11	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)
Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) SMART DENTURE CONVERSIONS, LLC Cleared 2026-06-11 Registered with US (FDA)	SMART DENTURE CONVERSIONS, LLC	2026-06-11	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)
WRAPSODY® Cell-Impermeable Endoprosthesis Merit Medical Systems, Inc. Cleared 2026-06-11 Registered with US (FDA)	Merit Medical Systems, Inc.	2026-06-11	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)
Rosetta SM, Rosetta SP Hass Corp. Cleared 2026-06-11 Registered with US (FDA)	Hass Corp.	2026-06-11	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)
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System Synthes USA Products, LLC Cleared 2026-06-11 Registered with US (FDA)	Synthes USA Products, LLC	2026-06-11	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)
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) FloShield, Inc. Cleared 2026-06-11 Registered with US (FDA)	FloShield, Inc.	2026-06-11	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)
Verge™ Microcatheter Instylla, Inc. Cleared 2026-06-11 Registered with US (FDA)	Instylla, Inc.	2026-06-11	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)
ICON 35; ICON 45; ICON 60; ICON 30FAF Rehasense USA, Inc. Cleared 2026-06-11 Registered with US (FDA)	Rehasense USA, Inc.	2026-06-11	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)
Dental X-ray System Changzhou Boen Zhongding Medical Technology Co Ltd Cleared 2026-06-11 Registered with US (FDA)	Changzhou Boen Zhongding Medical Technology Co Ltd	2026-06-11	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)
Anura Mobile Core SDK (M1) Nuralogix Corporation Cleared 2026-06-11 Registered with US (FDA)	Nuralogix Corporation	2026-06-11	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)
AViTA Breast Pump Avita Corporation Cleared 2026-06-11 Registered with US (FDA)	Avita Corporation	2026-06-11	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)
Fluoride Varnish (Type A,Type C) Nagy Oral Technology Qinhuangdao Co., Ltd. Cleared 2026-06-11 Registered with US (FDA)	Nagy Oral Technology Qinhuangdao Co., Ltd.	2026-06-11	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)
PROBEAT-CR Hitachi High-Tech Corporation Cleared 2026-06-11 Registered with US (FDA)	Hitachi High-Tech Corporation	2026-06-11	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)
Ion-L SurGenTec, LLC Cleared 2026-06-11 Registered with US (FDA)	SurGenTec, LLC	2026-06-11	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)
REGENT MECHANICAL HEART VALVE Abbott Medical Cleared 2026-06-11 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Abbott Medical	2026-06-11	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Respiration Rate algorithm Edwards Lifesciences, LLC Cleared 2026-06-11 Registered with US (FDA)	Edwards Lifesciences, LLC	2026-06-11	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)
i-STAT hs-TnI cartridge with the i-STAT Alinity System Abbott Point of Care, Inc. Cleared 2026-06-11 Registered with US (FDA)	Abbott Point of Care, Inc.	2026-06-11	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)
"Tech-Image" Video Endoscope System Tech-Image CO., LTD. Cleared 2026-06-10 Registered with US (FDA)	Tech-Image CO., LTD.	2026-06-10	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)
Profoject™ Safety Pen Needles Cmt Health Pte., Ltd. Cleared 2026-06-10 Registered with US (FDA)	Cmt Health Pte., Ltd.	2026-06-10	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 And Thermo Therapy System Xiamen Weiyou Intelligent Technology Co.,Ltd Cleared 2026-06-10 Registered with US (FDA)	Xiamen Weiyou Intelligent Technology Co.,Ltd	2026-06-10	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)
RxSight Insertion Device Rxsight, Inc. Cleared 2026-06-10 Registered with US (FDA) AU (TGA)	Rxsight, Inc.	2026-06-10	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Venovo Venous Stent System Bard Peripheral Vascular Inc Cleared 2026-06-10 Registered with US (FDA)	Bard Peripheral Vascular Inc	2026-06-10	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)
Tinnitus Therapy Sivantos GmbH Cleared 2026-06-10 Registered with US (FDA)	Sivantos GmbH	2026-06-10	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)
LARS ACJ Movmedix Cleared 2026-06-10 Registered with US (FDA)	Movmedix	2026-06-10	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)
Colli-Pee•Dx Urine Collection Kit DNA Genotek, Inc. Cleared 2026-06-10 Registered with US (FDA)	DNA Genotek, Inc.	2026-06-10	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)
MSS - Humeral reverse liners extension Medacta International S.A. Cleared 2026-06-10 Registered with US (FDA)	Medacta International S.A.	2026-06-10	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)
MediBeacon® Transdermal GFR Measurement System (GFR) Medibeacon, Inc. Cleared 2026-06-10 Registered with US (FDA)	Medibeacon, Inc.	2026-06-10	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)
LifeStent™ 5F Vascular Stent Systems Bard Peripheral Vascular Inc Cleared 2026-06-10 Registered with US (FDA)	Bard Peripheral Vascular Inc	2026-06-10	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)
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) Centerline Biomedical, Inc. Cleared 2026-06-10 Registered with US (FDA)	Centerline Biomedical, Inc.	2026-06-10	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)
Anteralign LS coverplate Tyber Medical, LLC Cleared 2026-06-10 Registered with US (FDA)	Tyber Medical, LLC	2026-06-10	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)
Penumbra System (Thunderbolt Aspiration Tubing) Penumbra, Inc. Cleared 2026-06-10 Registered with US (FDA)	Penumbra, Inc.	2026-06-10	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)
Covera™ Vascular Covered Stent C.R. Bard, Inc. Cleared 2026-06-10 Registered with US (FDA)	C.R. Bard, Inc.	2026-06-10	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)
DeepXray Spina Alpha Intelligence Manifolds, Inc. Cleared 2026-06-10 Registered with US (FDA)	Alpha Intelligence Manifolds, Inc.	2026-06-10	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)
BOBBY Balloon Guide Catheter MicroVention, Inc., d/b/a Terumo Neuro Cleared 2026-06-09 Registered with US (FDA)	MicroVention, Inc., d/b/a Terumo Neuro	2026-06-09	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)
LAP-iX2N Sejong Medical Co., Ltd. Cleared 2026-06-09 Registered with US (FDA)	Sejong Medical Co., Ltd.	2026-06-09	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)
Mother's Nature W1 Warming Wearable Breast Pump SHENZHEN TPH TECHNOLOGY CO., LTD. Cleared 2026-06-09 Registered with US (FDA)	SHENZHEN TPH TECHNOLOGY CO., LTD.	2026-06-09	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)
ENDOTAK,ENDOTAK ENDURANCE, ENDOTAK RELIANCE Boston Scientific Corp Cleared 2026-06-09 Registered with US (FDA)	Boston Scientific Corp	2026-06-09	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)