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
AccurECG Analysis System (v2.0) Accurkardia, Inc. Cleared 2025-12-22 Registered with US (FDA)	Accurkardia, Inc.	2025-12-22	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)
Theracor Stimlabs, LLC Cleared 2025-12-22 Registered with US (FDA)	Stimlabs, LLC	2025-12-22	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)
PERCEVAL SUTURELESS HEART VALVE Corcym Srl Cleared 2025-12-22 Registered with US (FDA)	Corcym Srl	2025-12-22	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)
RayStation (2024A SP3) RaySearch Laboratories AB (PUBL) Cleared 2025-12-22 Registered with US (FDA) UK (MHRA)	RaySearch Laboratories AB (PUBL)	2025-12-22	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Power wheelchair Zhenjiang Assure Medical Equipment Co., Ltd. Cleared 2025-12-22 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Zhenjiang Assure Medical Equipment Co., Ltd.	2025-12-22	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) Zhejiang Gongdong Medical Technology Co., Ltd. Cleared 2025-12-22 Registered with US (FDA)	Zhejiang Gongdong Medical Technology Co., Ltd.	2025-12-22	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)
DIMPLO Implant System Dimplo , Ltd. Cleared 2025-12-22 Registered with US (FDA)	Dimplo , Ltd.	2025-12-22	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)
MC2 Portable X-ray System OXOS MEDICAL, INC. Cleared 2025-12-22 Registered with US (FDA)	OXOS MEDICAL, INC.	2025-12-22	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)
ADATO SIL-OL 5000 Silicone Oils Bausch & Lomb Incorporated Cleared 2025-12-22 Registered with US (FDA)	Bausch & Lomb Incorporated	2025-12-22	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)
EmbraceMini Empatica S.R.L. Cleared 2025-12-22 Registered with US (FDA) UK (MHRA)	Empatica S.R.L.	2025-12-22	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
PeekMed web Peek Health, S.A. Cleared 2025-12-22 Registered with US (FDA) EU (EUDAMED)	Peek Health, S.A.	2025-12-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Instylla Delivery Kit Instylla, Inc. Cleared 2025-12-22 Registered with US (FDA) EU (EUDAMED)	Instylla, Inc.	2025-12-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Tetra (TM-20); Tetra (TM-50) Emed Technologies Corporation Cleared 2025-12-22 Registered with US (FDA)	Emed Technologies Corporation	2025-12-22	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)
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device ETHICON LLC Cleared 2025-12-22 Registered with US (FDA) AU (TGA)	ETHICON LLC	2025-12-22	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
InnoClip Clip Applier Taiwan Surgical Corporation Cleared 2025-12-22 Registered with US (FDA)	Taiwan Surgical Corporation	2025-12-22	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)
SKOUT system Iterative Health Cleared 2025-12-22 Registered with US (FDA)	Iterative Health	2025-12-22	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)
aprevo® cervical plating system Carlsmed, Inc. Cleared 2025-12-22 Registered with US (FDA)	Carlsmed, Inc.	2025-12-22	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)
LacertaMatrix Lacerta Life Science Cleared 2025-12-22 Registered with US (FDA)	Lacerta Life Science	2025-12-22	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)
Syndesmosis TightRope PRO Arthrex, Inc. Cleared 2025-12-22 Registered with US (FDA)	Arthrex, Inc.	2025-12-22	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)
KP Protective Face Mask Kp Trading Co., Ltd. Cleared 2025-12-22 Registered with US (FDA)	Kp Trading Co., Ltd.	2025-12-22	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)
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) Globus Medical, Inc. Cleared 2025-12-22 Registered with US (FDA)	Globus Medical, Inc.	2025-12-22	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)
Pression Wave PRO External Counter-Pulsation System Pression, Inc. Cleared 2025-12-22 Registered with US (FDA)	Pression, Inc.	2025-12-22	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)
CE Deliver (DLV) CapsoVision, Inc. Cleared 2025-12-19 Registered with US (FDA)	CapsoVision, Inc.	2025-12-19	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)
AI-CVD HeartLung Corporation Cleared 2025-12-19 Registered with US (FDA)	HeartLung Corporation	2025-12-19	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)
ProtekDilate Vascular Access Kit Sorin Group Italia S.R.L. Cleared 2025-12-19 Registered with US (FDA)	Sorin Group Italia S.R.L.	2025-12-19	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)
LCD Monitor (CL1902A, CL2103F) Shenzhen Beacon Display Technology Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Shenzhen Beacon Display Technology Co., Ltd.	2025-12-19	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)
EMPOWR Knee Encore Medical LP Cleared 2025-12-19 Registered with US (FDA)	Encore Medical LP	2025-12-19	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)
Rectal Applicator Nucletron Corp. Cleared 2025-12-19 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Nucletron Corp.	2025-12-19	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Southern Craniomaxillofacial (CMF) System Southern Medical (Pty) , Ltd. Cleared 2025-12-19 Registered with US (FDA)	Southern Medical (Pty) , Ltd.	2025-12-19	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)
HeartSync Multifunction Disposable Single-Use Defibrillator Pads Graphic Controls D.B.A. Vermed Cleared 2025-12-19 Registered with US (FDA)	Graphic Controls D.B.A. Vermed	2025-12-19	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)
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) Qingdao Bright Moon Biomedical Materials Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Qingdao Bright Moon Biomedical Materials Co., Ltd.	2025-12-19	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)
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer Surgical Instrument Service and Savings, Inc. Cleared 2025-12-19 Registered with US (FDA)	Surgical Instrument Service and Savings, Inc.	2025-12-19	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 Electric Breast Pump (YM-8803) Guangdong Youmeng Electrical Technology Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Guangdong Youmeng Electrical Technology Co., Ltd.	2025-12-19	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)
Cool Point™ Tubing Set Irvine Biomedical, Inc. Cleared 2025-12-19 Registered with US (FDA)	Irvine Biomedical, Inc.	2025-12-19	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)
STAR Apollo™ Mapping System Rhythm AI, Ltd. Cleared 2025-12-19 Registered with US (FDA)	Rhythm AI, Ltd.	2025-12-19	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)
Alzevita TOPIA MEDTECH LIMITED Cleared 2025-12-19 Registered with US (FDA)	TOPIA MEDTECH LIMITED	2025-12-19	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)
JOULE 1064nm System and Accessories Sciton, Inc. Cleared 2025-12-19 Registered with US (FDA)	Sciton, Inc.	2025-12-19	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)
MSFX MIKRON PEEK CAGES Mikron Makina Sanayi VE Tic. Ltd. Sti. Cleared 2025-12-19 Registered with US (FDA)	Mikron Makina Sanayi VE Tic. Ltd. Sti.	2025-12-19	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)
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise Siemens Healthcare GmbH Cleared 2025-12-19 Registered with US (FDA)	Siemens Healthcare GmbH	2025-12-19	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)
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) Medtronic, Inc Cleared 2025-12-19 Registered with US (FDA) AU (TGA)	Medtronic, Inc	2025-12-19	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Tru Liver Health Test Panel Truvian Health Cleared 2025-12-19 Registered with US (FDA)	Truvian Health	2025-12-19	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)
Airbile-100 POSKOM Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	POSKOM Co., Ltd.	2025-12-19	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)
MatriDerm pluS+ Bi-Layer Medskin Solutions Dr. Suwelack AG Cleared 2025-12-19 Registered with US (FDA)	Medskin Solutions Dr. Suwelack AG	2025-12-19	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 Therapy System (Model: LFS-D9U) Sanhe Lefis Electronics Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Sanhe Lefis Electronics Co., Ltd.	2025-12-19	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)
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. Cleared 2025-12-19 Registered with US (FDA)	Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.	2025-12-19	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)
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) Fisher &Paykel Healthcare , Ltd. Cleared 2025-12-19 Registered with US (FDA)	Fisher &Paykel Healthcare , Ltd.	2025-12-19	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)
Chiavaye Personal Moisturizer Unipack, LLC Cleared 2025-12-19 Registered with US (FDA)	Unipack, LLC	2025-12-19	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)
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) Medicrea International S.A.S. (Medtronic) Cleared 2025-12-19 Registered with US (FDA)	Medicrea International S.A.S. (Medtronic)	2025-12-19	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)
LIA Console (542-7) Leadoptik, Inc. Cleared 2025-12-19 Registered with US (FDA)	Leadoptik, Inc.	2025-12-19	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 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus DiaSorin, Inc. Cleared 2025-12-19 Registered with US (FDA)	DiaSorin, Inc.	2025-12-19	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)