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
EyeBOX SNAP Oculogica, Inc. Cleared 2026-06-05 Registered with US (FDA) Canada (Health Canada)	Oculogica, Inc.	2026-06-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VEOFIX Snap Off Screw Steps Ortho Cleared 2026-06-05 Registered with US (FDA)	Steps Ortho	2026-06-05	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)
Catalyze BioTissue Holdings, Inc. Cleared 2026-06-05 Registered with US (FDA)	BioTissue Holdings, Inc.	2026-06-05	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)
Prospera SCS System, Resilience Surgical Lead, Embrace One Biotronik Nro, Inc. Cleared 2026-06-05 Registered with US (FDA)	Biotronik Nro, Inc.	2026-06-05	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)
Alma TED+ System Alma Lasers , Ltd. Cleared 2026-06-05 Registered with US (FDA)	Alma Lasers , Ltd.	2026-06-05	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)
Power Wheelchair (N5515A, N5516, N5517A, N5519) Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Cleared 2026-06-05 Registered with US (FDA)	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	2026-06-05	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)
APTUS Clavicle System 2.8 Medartis, Inc. Cleared 2026-06-05 Registered with US (FDA)	Medartis, Inc.	2026-06-05	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)
Vial Adapter HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD. Cleared 2026-06-05 Registered with US (FDA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.	2026-06-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
PRO-Kinetic Energy Coronary Stent System Biotronik, GmbH & Co. Cleared 2026-06-05 Registered with US (FDA) UK (MHRA)	Biotronik, GmbH & Co.	2026-06-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test Assure Tech. Co., Ltd. Cleared 2026-06-05 Registered with US (FDA)	Assure Tech. Co., Ltd.	2026-06-05	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)
Perfect-O Ostial Positioning Catheter Balosmark, Inc. Cleared 2026-06-05 Registered with US (FDA)	Balosmark, Inc.	2026-06-05	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)
Precision S 4K Sinuscope Stryker Endoscopy Cleared 2026-06-04 Registered with US (FDA)	Stryker Endoscopy	2026-06-04	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)
HYDRUS MICROSTENT Alcon Research, Ltd. Cleared 2026-06-04 Registered with US (FDA)	Alcon Research, Ltd.	2026-06-04	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)
Instrument Exit Point on Touch Surgery™ Aide Covidien Cleared 2026-06-04 Registered with US (FDA)	Covidien	2026-06-04	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)
Dental Cone Beam Computed Tomography System Yofo Medical Technology Co., Ltd. Cleared 2026-06-04 Registered with US (FDA)	Yofo Medical Technology Co., Ltd.	2026-06-04	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)
Agili-C Smith & Nephew, Inc. Cleared 2026-06-04 Registered with US (FDA)	Smith & Nephew, Inc.	2026-06-04	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)
Respiratory Gating for Scanners (2.1) Varian Medical Systems inc Cleared 2026-06-04 Registered with US (FDA)	Varian Medical Systems inc	2026-06-04	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)
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) GT METABOLIC SOLUTIONS, INC. Cleared 2026-06-04 Registered with US (FDA)	GT METABOLIC SOLUTIONS, INC.	2026-06-04	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)
Spectra Platinum Mini Uzinmedicare Co. Cleared 2026-06-04 Registered with US (FDA)	Uzinmedicare Co.	2026-06-04	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)
Strauss Surgical Resection Instruments AMERICAN MEDICAL ENDOSCOPY, INC. Cleared 2026-06-04 Registered with US (FDA)	AMERICAN MEDICAL ENDOSCOPY, INC.	2026-06-04	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)
Orion ResMed PTY Ltd Cleared 2026-06-04 Registered with US (FDA)	ResMed PTY Ltd	2026-06-04	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)
Harmony Referral System with Harmony OCT Viewer (Octave) Topcon Healthcare Solutions EMEA Oy Cleared 2026-06-04 Registered with US (FDA)	Topcon Healthcare Solutions EMEA Oy	2026-06-04	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)
LumiGlam Laser System (SHE-LSP601-3) Beijing Sano Laser S&T Development Co.,Ltd Cleared 2026-06-04 Registered with US (FDA)	Beijing Sano Laser S&T Development Co.,Ltd	2026-06-04	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)
LUNA 3D LAP GmbH Laser Applikationen Cleared 2026-06-04 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	LAP GmbH Laser Applikationen	2026-06-04	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX DiaSorin, Inc. Cleared 2026-06-04 Registered with US (FDA)	DiaSorin, Inc.	2026-06-04	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)
Sonio Suspect Sonio Cleared 2026-06-04 Registered with US (FDA) EU (EUDAMED)	Sonio	2026-06-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) New York Embroidery Studio (NYES) Cleared 2026-06-04 Registered with US (FDA)	New York Embroidery Studio (NYES)	2026-06-04	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)
Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas) Cleared 2026-06-04 Registered with US (FDA)	Orthosoft Inc (D/B/A Zimmer Cas)	2026-06-04	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)
BOND ORACLE HER2 IHC SYSTEM Leica Biosystems Cleared 2026-06-04 Registered with US (FDA)	Leica Biosystems	2026-06-04	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)
DEEPVESSEL Plaque Keya Medical Technology Co., Ltd. Cleared 2026-06-04 Registered with US (FDA)	Keya Medical Technology Co., Ltd.	2026-06-04	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)
TroKit Laparoscope Lens Wiper TroCare, LLC Cleared 2026-06-04 Registered with US (FDA)	TroCare, LLC	2026-06-04	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)
MeRT System Wave Neuroscience Cleared 2026-06-03 Registered with US (FDA)	Wave Neuroscience	2026-06-03	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)
Alto Abdominal Stent Graft System Endologix, Inc. Cleared 2026-06-03 Registered with US (FDA) UK (MHRA)	Endologix, Inc.	2026-06-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
BioWave BioWraps Biowave Corporation Cleared 2026-06-03 Registered with US (FDA) AU (TGA)	Biowave Corporation	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Permatage Flowable, Settable Hemostatic Bone Paste Orthocon, LLC Cleared 2026-06-03 Registered with US (FDA)	Orthocon, LLC	2026-06-03	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)
SteriTite Container System with MediTray Products Case Medical, Inc. Cleared 2026-06-03 Registered with US (FDA)	Case Medical, Inc.	2026-06-03	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)
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl S&S Glove Corporation Cleared 2026-06-03 Registered with US (FDA)	S&S Glove Corporation	2026-06-03	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)
SIC Abutments including CAD/CAM Solutions SIC invent AG Cleared 2026-06-03 Registered with US (FDA)	SIC invent AG	2026-06-03	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)
BracePaste Prime Plus American Orthodontics Cleared 2026-06-03 Registered with US (FDA) Canada (Health Canada)	American Orthodontics	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
iiSure Infusion Set Deka Research & Development Corp. Cleared 2026-06-03 Registered with US (FDA)	Deka Research & Development Corp.	2026-06-03	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)
Electric Wheelchair (DF506) Jiangsu Yveelt Medical Equipment Co., Ltd. Cleared 2026-06-03 Registered with US (FDA)	Jiangsu Yveelt Medical Equipment Co., Ltd.	2026-06-03	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)
Tissue Approximation System Tas Medical, Inc. Cleared 2026-06-03 Registered with US (FDA)	Tas Medical, Inc.	2026-06-03	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)
Roosin Collagen Powder Roosin Medical Co, Ltd Cleared 2026-06-03 Registered with US (FDA)	Roosin Medical Co, Ltd	2026-06-03	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)
KARL STORZ Endoscopic Accessories for Urology Karl Storz SE & CO.KG Cleared 2026-06-03 Registered with US (FDA)	Karl Storz SE & CO.KG	2026-06-03	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)
HeartFocus Deski Cleared 2026-06-03 Registered with US (FDA)	Deski	2026-06-03	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)
ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM Boston Scientific Corp Cleared 2026-06-03 Registered with US (FDA)	Boston Scientific Corp	2026-06-03	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)
TECNIS™ 3-Piece Multifocal, Model ZMA00 Johnson&Johnson Surgical Vision Inc Cleared 2026-06-03 Registered with US (FDA)	Johnson&Johnson Surgical Vision Inc	2026-06-03	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)
CustoMED Viewer Customed, Inc. Cleared 2026-06-03 Registered with US (FDA) EU (EUDAMED)	Customed, Inc.	2026-06-03	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Upper arm electronic blood pressure monitor (XB-01) Shenzhen Ziqing Medical Equipment Co., Ltd. Cleared 2026-06-03 Registered with US (FDA)	Shenzhen Ziqing Medical Equipment Co., Ltd.	2026-06-03	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)
Scooter (YD-03) Yurob Rehabilitation Medical Co, Ltd Cleared 2026-06-03 Registered with US (FDA)	Yurob Rehabilitation Medical Co, Ltd	2026-06-03	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)