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
HardyDisk AST Gepotidacin 10µg (GEP10) Hardy Diagnostics Cleared 2026-05-11 Registered with US (FDA)	Hardy Diagnostics	2026-05-11	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)
ARCHITECT AFP Abbott Laboratories Cleared 2026-05-11 Registered with US (FDA)	Abbott Laboratories	2026-05-11	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)
PICO SHINING (PICO-K; PICOFY) Speclipse, Inc. Cleared 2026-05-11 Registered with US (FDA)	Speclipse, Inc.	2026-05-11	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)
Dual Core Vericom Co., Ltd. Cleared 2026-05-11 Registered with US (FDA)	Vericom Co., Ltd.	2026-05-11	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)
Pytheas Your Guided Trajectory PYTHEAS NAVIGATION SAS Cleared 2026-05-11 Registered with US (FDA) UK (MHRA)	PYTHEAS NAVIGATION SAS	2026-05-11	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Protable Phlegm Suction Unit (JMA D01) Jiangsu Jumao X-Care Medical Equipment Co.,Ltd Cleared 2026-05-11 Registered with US (FDA)	Jiangsu Jumao X-Care Medical Equipment Co.,Ltd	2026-05-11	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)
ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) Ethicon Endo-Surgery, Inc. Cleared 2026-05-11 Registered with US (FDA)	Ethicon Endo-Surgery, Inc.	2026-05-11	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)
Atellica IM Alpha Fetoprotein (AFP) Assay Siemens Healthcare Diagnostics Cleared 2026-05-11 Registered with US (FDA)	Siemens Healthcare Diagnostics	2026-05-11	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)
KARL STORZ Trocars with Valve Seals Karl Storz SE & CO.KG Cleared 2026-05-11 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-05-11	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)
Atellica IM free PSA II (fPSAII) Siemens Healthcare Diagnostics Cleared 2026-05-11 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Siemens Healthcare Diagnostics	2026-05-11	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system Carlsmed, Inc. Cleared 2026-05-09 Registered with US (FDA)	Carlsmed, Inc.	2026-05-09	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)
Avanti Distal Elbow ORIF System Avanti Orthopaedics, Inc. Cleared 2026-05-09 Registered with US (FDA)	Avanti Orthopaedics, Inc.	2026-05-09	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)
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) Elde Medikal Sanayi ve Ticaret Anonim Sirketi Cleared 2026-05-08 Registered with US (FDA)	Elde Medikal Sanayi ve Ticaret Anonim Sirketi	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)
Revanesse Versa, Revanesse Versa+ and Revanesse Lips+ Prollenium Medical Technologies, Inc. Cleared 2026-05-08 Registered with US (FDA)	Prollenium Medical Technologies, 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)
MiroCam Capsule Endoscope System Intromedic Co., Ltd. Cleared 2026-05-08 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Intromedic Co., Ltd.	2026-05-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
HipGuide (V 1.0.0.0) Orthopedic Driven Imaging, LLC Cleared 2026-05-08 Registered with US (FDA)	Orthopedic Driven Imaging, LLC	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)
LingOral Dental Design System Hangzhou ChohoTech Co., Ltd Cleared 2026-05-08 Registered with US (FDA)	Hangzhou ChohoTech 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)
Arthrex Beaming System Arthrex, Inc. Cleared 2026-05-08 Registered with US (FDA)	Arthrex, 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)
AerFrame Patient Immobilization System (AFPIS) Stabilix, LLC Cleared 2026-05-08 Registered with US (FDA)	Stabilix, LLC	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)
Modius Spero Neurovalens , Ltd. Cleared 2026-05-08 Registered with US (FDA)	Neurovalens , 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)
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) AU (TGA)	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)	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)
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)
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)
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 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)
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)
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)
Cannula with Guide AtriCure, Inc. Cleared 2026-05-06 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	AtriCure, Inc.	2026-05-06	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	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 Endoprosthesis with Unistep Plus Delivery System 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)
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)