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
CVAC Aspiration System Calyxo, Inc. Cleared 2026-04-13 Registered with US (FDA)	Calyxo, Inc.	2026-04-13	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)
ACORYS MAPPING SYSTEM Corify Care S.L Cleared 2026-04-13 Registered with US (FDA) UK (MHRA)	Corify Care S.L	2026-04-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
HVT 2.0 Vapotherm, Inc. Cleared 2026-04-13 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Vapotherm, Inc.	2026-04-13	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) 1987 Media Limited Cleared 2026-04-10 Registered with US (FDA)	1987 Media Limited	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)
LOBO Vascular Occlusion System Okami Medical Cleared 2026-04-10 Registered with US (FDA)	Okami Medical	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)
DIACORE ShenB Co., Ltd. Cleared 2026-04-10 Registered with US (FDA) EU (EUDAMED)	ShenB 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)	Registered with EU (EUDAMED)
ShaeferH Shaeferh, LLC Cleared 2026-04-10 Registered with US (FDA)	Shaeferh, LLC	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)
Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads Covidien (Part of Medtronic) Cleared 2026-04-10 Registered with US (FDA)	Covidien (Part of Medtronic)	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)
ABL90 FLEX PLUS System, safeCLINITUBES Radiometer Medicals Aps Cleared 2026-04-10 Registered with US (FDA)	Radiometer Medicals Aps	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)
CoAptix S System University of Utah, Department of Orthopaedics Cleared 2026-04-10 Registered with US (FDA)	University of Utah, Department of Orthopaedics	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)
DeepBT Detector-Plus Aitewan Biomedical Technology, Inc. Cleared 2026-04-10 Registered with US (FDA)	Aitewan Biomedical Technology, 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)
VRNT Cognifisense, Inc. Cleared 2026-04-10 Registered with US (FDA)	Cognifisense, 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)
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)
Accuro XV Rivanna Medical, LLC Cleared 2026-04-09 Registered with US (FDA)	Rivanna Medical, LLC	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)
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)
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)
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)