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
AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL (SA60WF); AcrySof Alcon Laboratories Cleared 2026-04-30 Registered with US (FDA)	Alcon Laboratories	2026-04-30	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)
AffloVest® Mobile Airway Clearance Therapy Tactile Medical Cleared 2026-04-30 Registered with US (FDA)	Tactile Medical	2026-04-30	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)
Cochlear Auditory Brainstem Implant System Cochlear Americas Cleared 2026-04-30 Registered with US (FDA)	Cochlear Americas	2026-04-30	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)
FSYX Ocular Pressure Adjusting Pump Balance Ophthalmics, Inc. Cleared 2026-04-30 Registered with US (FDA)	Balance Ophthalmics, Inc.	2026-04-30	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)
AllTest Strep A Rapid Test Hangzhou Alltest Biotech Co Ltd Cleared 2026-04-30 Registered with US (FDA)	Hangzhou Alltest Biotech Co Ltd	2026-04-30	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)
Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) Xiamen Weiyou Intelligent Technology Co.,Ltd Cleared 2026-04-30 Registered with US (FDA)	Xiamen Weiyou Intelligent Technology Co.,Ltd	2026-04-30	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)
SCRIPT™ Implant System Globus Medical, Inc. Cleared 2026-04-29 Registered with US (FDA)	Globus Medical, Inc.	2026-04-29	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)
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK Roche Diagnostics GmbH Cleared 2026-04-29 Registered with US (FDA) UK (MHRA)	Roche Diagnostics GmbH	2026-04-29	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LEO Spinal System ZheJiang Decans Medical Devices Co., Ltd. Cleared 2026-04-29 Registered with US (FDA)	ZheJiang Decans Medical Devices Co., Ltd.	2026-04-29	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)
syngo Application Software Siemens Medical Solutions USA, Inc. Cleared 2026-04-29 Registered with US (FDA)	Siemens Medical Solutions USA, Inc.	2026-04-29	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)
Break Wave Sonomotion, Inc. Cleared 2026-04-29 Registered with US (FDA)	Sonomotion, Inc.	2026-04-29	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)
Echo Large Bore Introducer Sheath Echo Medical, LLC Cleared 2026-04-29 Registered with US (FDA)	Echo Medical, LLC	2026-04-29	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)
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire Scientia Vascular, LLC Cleared 2026-04-29 Registered with US (FDA)	Scientia Vascular, LLC	2026-04-29	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)
YellowStar Asclepion Laser Technologies GmbH Cleared 2026-04-29 Registered with US (FDA)	Asclepion Laser Technologies GmbH	2026-04-29	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)
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES GEO MEDICAL CO., LTD. Cleared 2026-04-29 Registered with US (FDA)	GEO MEDICAL CO., LTD.	2026-04-29	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)
F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) BMC Medical Co, Ltd Cleared 2026-04-29 Registered with US (FDA)	BMC Medical Co, Ltd	2026-04-29	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)
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET Roche Diagnostics GmbH Cleared 2026-04-29 Registered with US (FDA) UK (MHRA)	Roche Diagnostics GmbH	2026-04-29	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) Shenzhen Root Innovation Technology Co., Ltd. Cleared 2026-04-29 Registered with US (FDA)	Shenzhen Root Innovation Technology Co., Ltd.	2026-04-29	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)
Paptizer 360 LiViliti Health Products Corporation Cleared 2026-04-29 Registered with US (FDA)	LiViliti Health Products Corporation	2026-04-29	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)
DeepHealth ProstateAI Quantib B.V. Cleared 2026-04-29 Registered with US (FDA)	Quantib B.V.	2026-04-29	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)
Arista™ AH Davol, Inc. Cleared 2026-04-29 Registered with US (FDA)	Davol, Inc.	2026-04-29	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)
Manual Wheelchair (7101L, 7102LHD) Foshan Nanhai Hongchen Medical Equipment Co., Ltd. Cleared 2026-04-28 Registered with US (FDA)	Foshan Nanhai Hongchen Medical Equipment Co., Ltd.	2026-04-28	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)
Anti-HCV Next Abbott Laboratories Cleared 2026-04-28 Registered with US (FDA)	Abbott Laboratories	2026-04-28	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)
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) Honsun(Nantong) Co., Ltd. Cleared 2026-04-28 Registered with US (FDA)	Honsun(Nantong) Co., Ltd.	2026-04-28	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)
Powerheart® G5 Zoll Medical Corp Cleared 2026-04-28 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Zoll Medical Corp	2026-04-28	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Cardinal Health™ Poly Reinforced Surgical Gown Cardinal Health 200 LLC Cleared 2026-04-28 Registered with US (FDA)	Cardinal Health 200 LLC	2026-04-28	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)
Surgical Microscope (OMS2360, OMS2380) Zumax Medical Co Ltd Cleared 2026-04-28 Registered with US (FDA)	Zumax Medical Co Ltd	2026-04-28	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)
Ultra-Fast Warm Kitazato Corporation Cleared 2026-04-28 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Kitazato Corporation	2026-04-28	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vacuum Pump (Model: AD-VPUM-500) Sheng Sheng Yi (Beijing) Technology Company Limited Cleared 2026-04-28 Registered with US (FDA)	Sheng Sheng Yi (Beijing) Technology Company Limited	2026-04-28	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)
SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx Guangzhou Wondfo Biotech Co, Ltd Cleared 2026-04-28 Registered with US (FDA)	Guangzhou Wondfo Biotech Co, Ltd	2026-04-28	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)
M.U.S.T. Pedicle Screw System - Extension Medacta International S.A. Cleared 2026-04-28 Registered with US (FDA)	Medacta International S.A.	2026-04-28	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)
SAM 3.0 Multi-Hour Continuous Ultrasound Device Zetroz Systems, LLC Cleared 2026-04-28 Registered with US (FDA)	Zetroz Systems, LLC	2026-04-28	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)
HEMOBLAST™ Bellows Dilon Technologies, LLC Cleared 2026-04-28 Registered with US (FDA)	Dilon Technologies, LLC	2026-04-28	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)
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) Dolanvy (Suzhou) Medical Technology Co., Ltd. Cleared 2026-04-28 Registered with US (FDA)	Dolanvy (Suzhou) Medical Technology Co., Ltd.	2026-04-28	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)
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) Joytech Healthcare Co. , Ltd. Cleared 2026-04-28 Registered with US (FDA)	Joytech Healthcare Co. , Ltd.	2026-04-28	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)
CASSIE Wesper, Inc. Cleared 2026-04-27 Registered with US (FDA)	Wesper, Inc.	2026-04-27	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)
Dura-Crown Hangzhou Shining3D Dental Technology Co., Ltd. Cleared 2026-04-27 Registered with US (FDA)	Hangzhou Shining3D Dental Technology Co., Ltd.	2026-04-27	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)
NovoKnee (SteriKnee) Novosource, Inc. Cleared 2026-04-27 Registered with US (FDA)	Novosource, Inc.	2026-04-27	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)
TearCare MGX System Sight Sciences, Inc. Cleared 2026-04-27 Registered with US (FDA)	Sight Sciences, Inc.	2026-04-27	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)
Fusion Bioline Vascular Graft Maquet Cardiovascular, LLC Cleared 2026-04-27 Registered with US (FDA) Canada (Health Canada)	Maquet Cardiovascular, LLC	2026-04-27	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Abre Venous Self-expanding Stent System Medtronic Vascular Cleared 2026-04-27 Registered with US (FDA)	Medtronic Vascular	2026-04-27	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)
Pelvic Floor Exerciser (PF01) Hunan Accurate Bio-Medical Technology Co., Ltd. Cleared 2026-04-27 Registered with US (FDA)	Hunan Accurate Bio-Medical Technology Co., Ltd.	2026-04-27	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)
SABER-C System Elevation Spine Cleared 2026-04-27 Registered with US (FDA)	Elevation Spine	2026-04-27	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)
Grandio disc multicolor Voco GmbH Cleared 2026-04-27 Registered with US (FDA)	Voco GmbH	2026-04-27	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)
Avenir® Müller Stem; Avenir Complete™ Hip System Zimmer Inc Cleared 2026-04-27 Registered with US (FDA)	Zimmer Inc	2026-04-27	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)
STA Satellite Max® Diagnostica Stago Cleared 2026-04-27 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Diagnostica Stago	2026-04-27	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) Tedan Surgical Innovations, LLC Cleared 2026-04-26 Registered with US (FDA)	Tedan Surgical Innovations, LLC	2026-04-26	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)
ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System Zsfab, Inc. Cleared 2026-04-24 Registered with US (FDA)	Zsfab, Inc.	2026-04-24	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)
POYA 3.5mm Medial Proximal Tibia System Bonebridge AG Cleared 2026-04-24 Registered with US (FDA)	Bonebridge AG	2026-04-24	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)
PC Fix System Chest Wall Innovations, Inc. Cleared 2026-04-24 Registered with US (FDA)	Chest Wall Innovations, Inc.	2026-04-24	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)