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.

3,708 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
Protaryx Transseptal Puncture Device (PTX2-001) Protaryx Medical, Inc. Cleared 2026-04-10 Registered with US (FDA)	Protaryx Medical, Inc.	2026-04-10	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)
Relu Cloud Relu BV Cleared 2026-04-10 Registered with US (FDA) EU (EUDAMED)	Relu BV	2026-04-10	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
SMART Osteotomy System Actis Medical Pty Ltd Cleared 2026-04-10 Registered with US (FDA) AU (TGA)	Actis Medical Pty Ltd	2026-04-10	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
AI-Rad Companion Organs RT Siemens Healthcare GmbH Cleared 2026-04-10 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Siemens Healthcare GmbH	2026-04-10	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
TherOx Downstream System Zoll Circulation Cleared 2026-04-10 Registered with US (FDA)	Zoll Circulation	2026-04-10	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)
Auryon Atherectomy System Eximo Medical, Ltd. Cleared 2026-04-10 Registered with US (FDA) UK (MHRA) AU (TGA)	Eximo Medical, Ltd.	2026-04-10	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
CeQur Simplicity™ On-Demand Insulin Delivery System Cequr SA Cleared 2026-04-10 Registered with US (FDA)	Cequr SA	2026-04-10	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)
syngo Dynamics (VA41F) Siemens Healthcare GmbH Cleared 2026-04-10 Registered with US (FDA)	Siemens Healthcare GmbH	2026-04-10	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)
TRIOS Dx (R1) 3Shape TRIOS AS Cleared 2026-04-10 Registered with US (FDA)	3Shape TRIOS AS	2026-04-10	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)
Overjet Iris Intelligent Imaging System Overjet, Inc. Cleared 2026-04-10 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Overjet, Inc.	2026-04-10	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Freestyle Mini Hands-free Medela, Inc. Cleared 2026-04-10 Registered with US (FDA) Canada (Health Canada)	Medela, Inc.	2026-04-10	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Teleport Glide Microcatheter OrbusNeich Medical (Shenzhen) Co., Ltd. Cleared 2026-04-10 Registered with US (FDA)	OrbusNeich Medical (Shenzhen) Co., Ltd.	2026-04-10	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)
BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder Becton Dickinson and Company Cleared 2026-04-10 Registered with US (FDA)	Becton Dickinson and Company	2026-04-10	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)
AeroDR TX c02 DK Medical Systems Co., Ltd. Cleared 2026-04-10 Registered with US (FDA)	DK Medical Systems Co., Ltd.	2026-04-10	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)
ARION ARC System Plasma Surgical, Ltd. Cleared 2026-04-10 Registered with US (FDA)	Plasma Surgical, Ltd.	2026-04-10	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)
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube Becton Dickinson and Company Cleared 2026-04-10 Registered with US (FDA)	Becton Dickinson and Company	2026-04-10	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)
Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) Shanghai Draeger Medical Instrument Co., Ltd. Cleared 2026-04-10 Registered with US (FDA)	Shanghai Draeger Medical Instrument Co., Ltd.	2026-04-10	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)
Ascblue (8010) Ascblue Corporation Cleared 2026-04-10 Registered with US (FDA)	Ascblue Corporation	2026-04-10	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)
Pressio 3 Multi-parameter Neuromonitoring System Sophysa SA Cleared 2026-04-10 Registered with US (FDA)	Sophysa SA	2026-04-10	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)
Porcelain Etch Gel Belport Company, Inc., Gingi-Pak Cleared 2026-04-10 Registered with US (FDA)	Belport Company, Inc., Gingi-Pak	2026-04-10	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)
SILKBridge KLISBio S.r.l. Cleared 2026-04-09 Registered with US (FDA)	KLISBio S.r.l.	2026-04-09	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)
Seaman Pro/Seaman Checkcells, Inc. Cleared 2026-04-09 Registered with US (FDA)	Checkcells, Inc.	2026-04-09	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)
Picosecond Nd:YAG Laser Systems (Model: HS-298) Shanghai Apolo Medical Technology Co., Ltd. Cleared 2026-04-09 Registered with US (FDA)	Shanghai Apolo Medical Technology Co., Ltd.	2026-04-09	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)
Radical 6F Access Catheter Maduro Medical, Inc. Cleared 2026-04-09 Registered with US (FDA)	Maduro Medical, Inc.	2026-04-09	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)
Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) Anhui Happiness Workshop Instruments Co., Ltd. Cleared 2026-04-09 Registered with US (FDA)	Anhui Happiness Workshop Instruments Co., Ltd.	2026-04-09	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)
LOCATOR Angled Abutment Zest Anchors, LLC Cleared 2026-04-09 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Zest Anchors, LLC	2026-04-09	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
RCT800 Ray Co., Ltd. Cleared 2026-04-09 Registered with US (FDA)	Ray Co., Ltd.	2026-04-09	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)
PLASMAFLO OP-05W (A) ASAHI KASEI MEDICAL CO., LTD. Cleared 2026-04-09 Registered with US (FDA)	ASAHI KASEI MEDICAL CO., LTD.	2026-04-09	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)
Eternal Art Porcelain Powders Shandong Huge Dental Material Corporation Cleared 2026-04-09 Registered with US (FDA)	Shandong Huge Dental Material Corporation	2026-04-09	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)
Artelon Convenience Kits International Life Sciences Cleared 2026-04-09 Registered with US (FDA)	International Life Sciences	2026-04-09	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)
EASYMADE-TI CG Bio Co., Ltd. Cleared 2026-04-09 Registered with US (FDA)	CG Bio Co., Ltd.	2026-04-09	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)
Apex Locator (FindPex) Changzhou Sifary Medical Technology Co, Ltd, Cleared 2026-04-08 Registered with US (FDA) Canada (Health Canada)	Changzhou Sifary Medical Technology Co, Ltd,	2026-04-08	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Hemoclip Hangzhou AGS MedTech Co., Ltd. Cleared 2026-04-08 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Hangzhou AGS MedTech Co., Ltd.	2026-04-08	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
LimiFlex Dynamic Sagittal Tether Empirical Spine, Inc. Cleared 2026-04-08 Registered with US (FDA)	Empirical Spine, Inc.	2026-04-08	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)
Celerity 5 HP Biological Indicator (LCB052) STERIS SAS Cleared 2026-04-08 Registered with US (FDA)	STERIS SAS	2026-04-08	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)
myAir ResMed PTY Ltd Cleared 2026-04-08 Registered with US (FDA) AU (TGA)	ResMed PTY Ltd	2026-04-08	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap Cmt Health Pte., Ltd. Cleared 2026-04-08 Registered with US (FDA)	Cmt Health Pte., Ltd.	2026-04-08	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)
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) Macrolux Medical Technology Co., Ltd. Cleared 2026-04-08 Registered with US (FDA)	Macrolux Medical Technology Co., Ltd.	2026-04-08	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)
TL-10 Laparoscopic Scope Cleaner Scopix , Ltd. Cleared 2026-04-08 Registered with US (FDA)	Scopix , Ltd.	2026-04-08	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)
Wearable Breast Pump (Model S21A) SHENZHEN TPH TECHNOLOGY CO., LTD. Cleared 2026-04-08 Registered with US (FDA)	SHENZHEN TPH TECHNOLOGY CO., LTD.	2026-04-08	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)
iStent Trabecular Micro-Bypass Stent System Glaukos Cleared 2026-04-08 Registered with US (FDA)	Glaukos	2026-04-08	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)
Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) Suzhou Shenyun Medical Equipment Co., Ltd. Cleared 2026-04-08 Registered with US (FDA)	Suzhou Shenyun Medical Equipment Co., Ltd.	2026-04-08	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)
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) Shenzhen Root Innovation Technology Co., Ltd. Cleared 2026-04-08 Registered with US (FDA)	Shenzhen Root Innovation Technology Co., Ltd.	2026-04-08	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)
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 STERIS SAS Cleared 2026-04-08 Registered with US (FDA)	STERIS SAS	2026-04-08	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)
OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) Boston Scientific Corp Cleared 2026-04-08 Registered with US (FDA)	Boston Scientific Corp	2026-04-08	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)
CATAMARAN SI Joint Fusion System Tenon Medical, Inc. Cleared 2026-04-08 Registered with US (FDA)	Tenon Medical, Inc.	2026-04-08	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)
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) Anumana, Inc. Cleared 2026-04-07 Registered with US (FDA)	Anumana, Inc.	2026-04-07	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)
Elecsys Anti-HBc II Roche Diagnostics GmbH Cleared 2026-04-07 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Roche Diagnostics GmbH	2026-04-07	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
AuST Steerable Sheath Centerpoint Systems Cleared 2026-04-07 Registered with US (FDA) Canada (Health Canada)	Centerpoint Systems	2026-04-07	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Power Wheelchair (OS-R-M01S) Beijing OrionStar Technology Co, Ltd Cleared 2026-04-07 Registered with US (FDA)	Beijing OrionStar Technology Co, Ltd	2026-04-07	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)