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
Wound Geni NPWT System Bechtel Medical, Inc. Cleared 2026-05-04 Registered with US (FDA)	Bechtel Medical, Inc.	2026-05-04	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)
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2026-05-04 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2026-05-04	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)
Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) Leaseir Technologies, Slu Cleared 2026-05-04 Registered with US (FDA)	Leaseir Technologies, Slu	2026-05-04	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)
ArteraAI Breast Artera Inc Cleared 2026-05-04 Registered with US (FDA)	Artera Inc	2026-05-04	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)
Male Latex Condom HA Okamoto USA, Inc. Cleared 2026-05-04 Registered with US (FDA)	Okamoto USA, Inc.	2026-05-04	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)
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) Amsino International, Inc. Cleared 2026-05-04 Registered with US (FDA)	Amsino International, Inc.	2026-05-04	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)
VISTAKON® (senofilcon A) contact lenses Vistakon, Division of Johnson & Johnson Vision Car Cleared 2026-05-04 Registered with US (FDA)	Vistakon, Division of Johnson & Johnson Vision Car	2026-05-04	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)
MammoSightAI Neurocareai, Inc. (Dba Savelife.Ai) Cleared 2026-05-04 Registered with US (FDA)	Neurocareai, Inc. (Dba Savelife.Ai)	2026-05-04	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)
Neowise Cefla S.C. Cleared 2026-05-04 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Cefla S.C.	2026-05-04	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine Merz North America, Inc. Cleared 2026-05-03 Registered with US (FDA)	Merz North America, Inc.	2026-05-03	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)
Zeta Navigation System Zeta Surgical Cleared 2026-05-01 Registered with US (FDA)	Zeta Surgical	2026-05-01	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)
BIOMONITOR IV (471155) Biotronik, GmbH & Co. Cleared 2026-05-01 Registered with US (FDA) AU (TGA)	Biotronik, GmbH & Co.	2026-05-01	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Any-Com Seal Mediclus Co., Ltd. Cleared 2026-05-01 Registered with US (FDA)	Mediclus Co., Ltd.	2026-05-01	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)
Ancora-SB Aspero Medical, Inc. Cleared 2026-05-01 Registered with US (FDA)	Aspero Medical, Inc.	2026-05-01	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)
PERLA® TL Posterior Thoraco-lumbar Fixation System Spineart Cleared 2026-05-01 Registered with US (FDA)	Spineart	2026-05-01	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)
Phototherapy System (DUV-COMBO) Choyang Medics Co., Ltd. Cleared 2026-05-01 Registered with US (FDA)	Choyang Medics Co., Ltd.	2026-05-01	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)
Tutamen Self Adhesive Electrodes Dongguan Tutamen Metalwork Co., Ltd. Cleared 2026-05-01 Registered with US (FDA)	Dongguan Tutamen Metalwork Co., Ltd.	2026-05-01	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)
Capnostream™35 Portable Respiratory Monitor (PM35MN) Covidien Cleared 2026-05-01 Registered with US (FDA)	Covidien	2026-05-01	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)
EndoTool IV Cloud 1.0 Glooko, Inc. Cleared 2026-05-01 Registered with US (FDA)	Glooko, Inc.	2026-05-01	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)
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) Philips Medizin Systeme Cleared 2026-05-01 Registered with US (FDA)	Philips Medizin Systeme	2026-05-01	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)
Ranger™ Paclitaxel-Coated PTA Balloon Catheter Boston Scientific Corp Cleared 2026-05-01 Registered with US (FDA) UK (MHRA) AU (TGA)	Boston Scientific Corp	2026-05-01	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
VOCO Profluorid Varnish + BioMin Voco GmbH Cleared 2026-05-01 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Voco GmbH	2026-05-01	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
ArthroTAK Tendon Anchor Kit ArthroTAK, LLC Cleared 2026-05-01 Registered with US (FDA)	ArthroTAK, LLC	2026-05-01	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)
BioCode Respiratory Pathogen Panel (RPP) Applied BioCode, Inc. Cleared 2026-05-01 Registered with US (FDA)	Applied BioCode, Inc.	2026-05-01	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 Radiometer Medicals Aps Cleared 2026-05-01 Registered with US (FDA)	Radiometer Medicals Aps	2026-05-01	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)
Prolystica Pass Thru Disinfectant Wipes STERIS SAS Cleared 2026-05-01 Registered with US (FDA)	STERIS SAS	2026-05-01	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)
FX V135 EASYTECH® Shoulder System FX Shoulder Solutions Cleared 2026-05-01 Registered with US (FDA)	FX Shoulder Solutions	2026-05-01	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)
Oxiplex® Fziomed, Inc. Cleared 2026-05-01 Registered with US (FDA) UK (MHRA) AU (TGA)	Fziomed, Inc.	2026-05-01	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Verifine Safety Lancets Promisemed Hangzhou Meditech Co., Ltd. Cleared 2026-05-01 Registered with US (FDA)	Promisemed Hangzhou Meditech Co., Ltd.	2026-05-01	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)
OSSIOfiber® Threaded Trimmable Fixation Nail OSSIO , Ltd. Cleared 2026-05-01 Registered with US (FDA)	OSSIO , Ltd.	2026-05-01	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)
Proclaim™ Dorsal Root Ganglion (DRG) IPG Abbott Medical Cleared 2026-04-30 Registered with US (FDA)	Abbott Medical	2026-04-30	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)
GORE® VIABAHN® FORTEGRA Venous Stent W. L. Gore and Associates, Inc. Cleared 2026-04-30 Registered with US (FDA) UK (MHRA)	W. L. Gore and Associates, Inc.	2026-04-30	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
c-med0 alpha Cosinuss GmbH Cleared 2026-04-30 Registered with US (FDA)	Cosinuss GmbH	2026-04-30	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)
UltraEZ Ultradent Products, Inc. Cleared 2026-04-30 Registered with US (FDA)	Ultradent Products, Inc.	2026-04-30	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)
Ambu® Virobac II® Exhalation Filter Ambu AS Cleared 2026-04-30 Registered with US (FDA)	Ambu AS	2026-04-30	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)
Intelligent NR Canon, Inc. Cleared 2026-04-30 Registered with US (FDA)	Canon, Inc.	2026-04-30	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)
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Cochlear Americas Cleared 2026-04-30 Registered with US (FDA)	Cochlear Americas	2026-04-30	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)
Cochlear Hybrid Implant System Cochlear Americas Cleared 2026-04-30 Registered with US (FDA)	Cochlear Americas	2026-04-30	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)
Infinity™ Deep Brain Stimulation (DBS) IPG; Liberta RC™ DBS IPG Abbott Medical Cleared 2026-04-30 Registered with US (FDA)	Abbott Medical	2026-04-30	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)
MEL 90 Excimer Laser Carl Zeiss Meditec AG Cleared 2026-04-30 Registered with US (FDA) Canada (Health Canada)	Carl Zeiss Meditec AG	2026-04-30	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BEE PLIF Cage NGMedical GmbH Cleared 2026-04-30 Registered with US (FDA)	NGMedical GmbH	2026-04-30	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)
Synapse 3D Base Tools (V7.2) FUJIFILM Corporation Cleared 2026-04-30 Registered with US (FDA)	FUJIFILM Corporation	2026-04-30	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)
Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD Medtronic, Inc Cleared 2026-04-30 Registered with US (FDA) AU (TGA)	Medtronic, Inc	2026-04-30	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
BloodSTOP iX Trauma Matrix (TM-iX-20) Lifescience Plus, Inc. Cleared 2026-04-30 Registered with US (FDA)	Lifescience Plus, Inc.	2026-04-30	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)
ISPAN Perfluoropropane C3F8 Gas AIRGAS THERAPEUTICS, LLC Cleared 2026-04-30 Registered with US (FDA)	AIRGAS THERAPEUTICS, LLC	2026-04-30	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)
OrthoPediatrics® Locking Cannulated Blade Plate System Orthopediatrics, LLC Cleared 2026-04-30 Registered with US (FDA)	Orthopediatrics, LLC	2026-04-30	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)
Aurie System Cathbuddy, Inc. Cleared 2026-04-30 Registered with US (FDA)	Cathbuddy, Inc.	2026-04-30	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)
Bayesian Health Sepsis Flagging Device Bayesian Health, Inc. Cleared 2026-04-30 Registered with US (FDA)	Bayesian Health, Inc.	2026-04-30	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)
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) Kms Medical Technology Co., Ltd. Cleared 2026-04-30 Registered with US (FDA)	Kms Medical Technology Co., Ltd.	2026-04-30	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)
iLet® ACE Pump Beta Bionics, Inc. Cleared 2026-04-30 Registered with US (FDA)	Beta Bionics, Inc.	2026-04-30	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)