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
Denture Base Shandong Huge Dental Material Corporation Cleared 2026-05-06 Registered with US (FDA)	Shandong Huge Dental Material 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)
Synergy Ablation System AtriCure, Inc. Cleared 2026-05-06 Registered with US (FDA)	AtriCure, Inc.	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)
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD Cleared 2026-05-05 Registered with US (FDA)	SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD	2026-05-05	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)
alfapump System Sequana Medical NV Cleared 2026-05-05 Registered with US (FDA)	Sequana Medical NV	2026-05-05	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)
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) Wenzhou Lingfeng Electronic Technology Co., Ltd. Cleared 2026-05-05 Registered with US (FDA)	Wenzhou Lingfeng Electronic Technology Co., Ltd.	2026-05-05	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)
Lumify Diagnostic Ultrasound System Philips Ultrasound, Inc. Cleared 2026-05-05 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Philips Ultrasound, Inc.	2026-05-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Healium Intelliscan LX192LC Healium Intelliscan Corporation Cleared 2026-05-05 Registered with US (FDA)	Healium Intelliscan Corporation	2026-05-05	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)
MectaLIF 3D Metal Anterior Medacta International S.A. Cleared 2026-05-05 Registered with US (FDA)	Medacta International S.A.	2026-05-05	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)
CentriMag Circulatory Support System Abbott GmbH Cleared 2026-05-05 Registered with US (FDA)	Abbott GmbH	2026-05-05	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)
Altius® Direct Electrical Nerve Stimulation System Neuros Medical, Inc. Cleared 2026-05-05 Registered with US (FDA)	Neuros Medical, Inc.	2026-05-05	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)
AccelFix Spinal Fixation System L&K BIOMED CO., LTD Cleared 2026-05-05 Registered with US (FDA)	L&K BIOMED CO., LTD	2026-05-05	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)
Q-Switched Nd:YAG laser systems Shanghai Apolo Medical Technology Co., Ltd. Cleared 2026-05-04 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Shanghai Apolo Medical Technology Co., Ltd.	2026-05-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
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)
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)
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)
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)
Any-Com Seal Mediclus Co., Ltd. Cleared 2026-05-01 Registered with US (FDA) EU (EUDAMED)	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)	Registered with EU (EUDAMED)
UltraEZ Ultradent Products, Inc. Cleared 2026-04-30 Registered with US (FDA) EU (EUDAMED)	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)	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) AU (TGA)	W. L. Gore and Associates, Inc.	2026-04-30	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	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)
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)
Nucleus Hybrid L24 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)
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)
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)