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
AYON Body Contouring System (AYON SYSTEM) Apyx Medical Corporation Cleared 2026-05-08 Registered with US (FDA)	Apyx Medical Corporation	2026-05-08	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)
Smylio Aligners Smylio, Inc. Cleared 2026-05-08 Registered with US (FDA)	Smylio, Inc.	2026-05-08	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)
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA Orthofix Srl Cleared 2026-05-08 Registered with US (FDA)	Orthofix Srl	2026-05-08	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)
DeepSkin (DEP100) El Global Trade, Ltd. Cleared 2026-05-08 Registered with US (FDA)	El Global Trade, Ltd.	2026-05-08	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 Stone Retrieval Balloon Catheter Zhejiang Soudon Medical Technology Co., Ltd. Cleared 2026-05-08 Registered with US (FDA)	Zhejiang Soudon Medical Technology Co., Ltd.	2026-05-08	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 SSA-60; Alegria Flash SSA-52; Alegria FLash SSB Zeus Scientific, Inc. Cleared 2026-05-08 Registered with US (FDA)	Zeus Scientific, Inc.	2026-05-08	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)
Veritas Reverse Total Shoulder System Restor3d Cleared 2026-05-07 Registered with US (FDA)	Restor3d	2026-05-07	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)
CO2 Laser Machine (Monica-I,Monica-II) Nanjing Bestview Laser S&T Co., Ltd. Cleared 2026-05-07 Registered with US (FDA)	Nanjing Bestview Laser S&T Co., Ltd.	2026-05-07	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 (SVS) Gyrus Acmi, Inc. Cleared 2026-05-07 Registered with US (FDA)	Gyrus Acmi, Inc.	2026-05-07	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)
Evita V800, Evita V600 DRAEGERWERK AG & CO. KGAA Cleared 2026-05-07 Registered with US (FDA)	DRAEGERWERK AG & CO. KGAA	2026-05-07	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)
SIR-Spheres® Y-90 resin microspheres SIRTEX MEDICAL, INC. Cleared 2026-05-07 Registered with US (FDA) UK (MHRA) AU (TGA)	SIRTEX MEDICAL, INC.	2026-05-07	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva Biotronik, GmbH & Co. Cleared 2026-05-07 Registered with US (FDA)	Biotronik, GmbH & Co.	2026-05-07	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)
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module Heidelberg Engineering Cleared 2026-05-07 Registered with US (FDA)	Heidelberg Engineering	2026-05-07	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)
MR Conditional Cup Electrodes Technomed Europe Cleared 2026-05-07 Registered with US (FDA)	Technomed Europe	2026-05-07	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)
LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus DiaSorin, Inc. Cleared 2026-05-07 Registered with US (FDA)	DiaSorin, Inc.	2026-05-07	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™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System Globus Medical, Inc. Cleared 2026-05-07 Registered with US (FDA)	Globus Medical, Inc.	2026-05-07	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)
LifePulse High Frequency Ventilator (LifePulse HFV) Model 204 Bunnell, Inc. Cleared 2026-05-07 Registered with US (FDA)	Bunnell, Inc.	2026-05-07	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)
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter; Sh Shockwave Medical., Inc. Cleared 2026-05-07 Registered with US (FDA)	Shockwave Medical., Inc.	2026-05-07	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)
Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle Galvanize Therapeutics, Inc Cleared 2026-05-07 Registered with US (FDA)	Galvanize Therapeutics, Inc	2026-05-07	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)
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue Institut Straumann AG Cleared 2026-05-07 Registered with US (FDA)	Institut Straumann AG	2026-05-07	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)
Lynx Aspiration Catheter System Q'Apel Medical Cleared 2026-05-07 Registered with US (FDA)	Q'Apel Medical	2026-05-07	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)
ROTAPRO Rotational Atherectomy System Boston Scientific Corp Cleared 2026-05-06 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Boston Scientific Corp	2026-05-06	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
WALLSTENT™ Venous Endoprosthesis with Unistep™ Plus Delivery System Boston Scientific Corp Cleared 2026-05-06 Registered with US (FDA)	Boston Scientific Corp	2026-05-06	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)
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) Biozen, LLC Cleared 2026-05-06 Registered with US (FDA)	Biozen, LLC	2026-05-06	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)
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff NIHON KOHDEN CORPORATION Cleared 2026-05-06 Registered with US (FDA)	NIHON KOHDEN CORPORATION	2026-05-06	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™ Vascular Self-Expanding Stent System Boston Scientific Corp Cleared 2026-05-06 Registered with US (FDA)	Boston Scientific Corp	2026-05-06	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)
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM Boston Scientific Corp Cleared 2026-05-06 Registered with US (FDA)	Boston Scientific Corp	2026-05-06	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)
CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M01A02); CareLink SmartSync Hos Medtronic, Inc Cleared 2026-05-06 Registered with US (FDA)	Medtronic, Inc	2026-05-06	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 Rehabilitation Therapy Device (PD2301/PD2302/PD2303) Shenzhen Changkun Technology Co., Ltd. Cleared 2026-05-06 Registered with US (FDA)	Shenzhen Changkun Technology Co., Ltd.	2026-05-06	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)
EPi-Sense and EPi-Sense ST Guided Coagulation System AtriCure, Inc. Cleared 2026-05-06 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	AtriCure, Inc.	2026-05-06	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Anchor with Fiber Wire and Disposable Inserter Ortobio S.A. Cleared 2026-05-06 Registered with US (FDA)	Ortobio S.A.	2026-05-06	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)
CastleLoc-P Anterior Cervical Plate System L&K BIOMED CO., LTD Cleared 2026-05-06 Registered with US (FDA)	L&K BIOMED CO., LTD	2026-05-06	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)
WALLSTENT ILIAC RP Endoprosthesis BOSTON SCIENTIFIC SCIMED Cleared 2026-05-06 Registered with US (FDA)	BOSTON SCIENTIFIC SCIMED	2026-05-06	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)
KardiaPSI Balloon Catheter Intervention Tech, Inc. ; dba Corvention Cleared 2026-05-06 Registered with US (FDA)	Intervention Tech, Inc. ; dba Corvention	2026-05-06	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 Self-Expanding Stent System Boston Scientific Corp Cleared 2026-05-06 Registered with US (FDA)	Boston Scientific Corp	2026-05-06	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)
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ Teleflex Medical Sdn Bhd Cleared 2026-05-06 Registered with US (FDA)	Teleflex Medical Sdn Bhd	2026-05-06	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)
QIAGEN therascreen® FGFR RGQ RT-PCR Kit QIAGEN GmbH Cleared 2026-05-06 Registered with US (FDA) Canada (Health Canada)	QIAGEN GmbH	2026-05-06	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Denture Base Shandong Huge Dental Material Corporation Cleared 2026-05-06 Registered with US (FDA)	Shandong Huge Dental Material Corporation	2026-05-06	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)
LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. Cleared 2026-05-06 Registered with US (FDA) Canada (Health Canada)	Physio-Control, Inc.	2026-05-06	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Synergy Ablation System AtriCure, Inc. Cleared 2026-05-06 Registered with US (FDA)	AtriCure, Inc.	2026-05-06	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)
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD Cleared 2026-05-05 Registered with US (FDA)	SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD	2026-05-05	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)
alfapump System Sequana Medical NV Cleared 2026-05-05 Registered with US (FDA)	Sequana Medical NV	2026-05-05	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 Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) Wenzhou Lingfeng Electronic Technology Co., Ltd. Cleared 2026-05-05 Registered with US (FDA)	Wenzhou Lingfeng Electronic Technology Co., Ltd.	2026-05-05	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)
Lumify Diagnostic Ultrasound System Philips Ultrasound, Inc. Cleared 2026-05-05 Registered with US (FDA) EU (EUDAMED)	Philips Ultrasound, Inc.	2026-05-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Healium Intelliscan LX192LC Healium Intelliscan Corporation Cleared 2026-05-05 Registered with US (FDA)	Healium Intelliscan Corporation	2026-05-05	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)
MectaLIF 3D Metal Anterior Medacta International S.A. Cleared 2026-05-05 Registered with US (FDA)	Medacta International S.A.	2026-05-05	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)
CentriMag Circulatory Support System Abbott GmbH Cleared 2026-05-05 Registered with US (FDA)	Abbott GmbH	2026-05-05	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)
Altius® Direct Electrical Nerve Stimulation System Neuros Medical, Inc. Cleared 2026-05-05 Registered with US (FDA)	Neuros Medical, Inc.	2026-05-05	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)
AccelFix Spinal Fixation System L&K BIOMED CO., LTD Cleared 2026-05-05 Registered with US (FDA)	L&K BIOMED CO., LTD	2026-05-05	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)
Q-Switched Nd:YAG laser systems Shanghai Apolo Medical Technology Co., Ltd. Cleared 2026-05-04 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Shanghai Apolo Medical Technology Co., Ltd.	2026-05-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)