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
CURIS II RF Generator (REF 360100-05) Sutter Medizintechnik GmbH Cleared 2026-02-11 Registered with US (FDA)	Sutter Medizintechnik GmbH	2026-02-11	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)
AXS Lift Intracranial Base Catheter STRYKER NEUROVASCULAR Cleared 2026-02-11 Registered with US (FDA) Canada (Health Canada) AU (TGA)	STRYKER NEUROVASCULAR	2026-02-11	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
ArmSure Fluoroscopic Positioning System Savfe Co. , Ltd. Cleared 2026-02-11 Registered with US (FDA)	Savfe Co. , Ltd.	2026-02-11	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)
Delivery Date AI Ultrasound AI Cleared 2026-02-11 Registered with US (FDA)	Ultrasound AI	2026-02-11	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)
Minima Stent System Renata Medical, Inc. Cleared 2026-02-11 Registered with US (FDA)	Renata Medical, Inc.	2026-02-11	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)
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cleared 2026-02-11 Registered with US (FDA)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-02-11	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)
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN UROMEDICA, INC. Cleared 2026-02-11 Registered with US (FDA)	UROMEDICA, INC.	2026-02-11	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)
LANDR Contact LENS Case Fourth Axis, LLC Cleared 2026-02-10 Registered with US (FDA)	Fourth Axis, LLC	2026-02-10	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)
Optimum Infinite (tisilfocon A) Orthokeratology Lenses II Contamac, Ltd. Cleared 2026-02-10 Registered with US (FDA)	Contamac, Ltd.	2026-02-10	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)
SpaceOAR Vue System (SV-2101) Boston Scientific Corp Cleared 2026-02-10 Registered with US (FDA)	Boston Scientific Corp	2026-02-10	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)
XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm Biodynamik, Inc. Cleared 2026-02-10 Registered with US (FDA)	Biodynamik, Inc.	2026-02-10	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)
CollOvine™ Wound Powder Ovigenex, LLC Cleared 2026-02-10 Registered with US (FDA)	Ovigenex, LLC	2026-02-10	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)
MI View&GO Siemens Medical Solutions USA, Inc. Cleared 2026-02-10 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Siemens Medical Solutions USA, Inc.	2026-02-10	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VISCOAT™ Ophthalmic Viscosurgical Device Alcon Laboratories Cleared 2026-02-10 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Alcon Laboratories	2026-02-10	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only Shenzhen RF Tech Co., Ltd. Cleared 2026-02-10 Registered with US (FDA)	Shenzhen RF Tech Co., Ltd.	2026-02-10	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)
multiFlux 130 (F00013123); multiFlux 160 (F00013124) Fresenius Medical Care Renal Therapies Group, LLC Cleared 2026-02-10 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2026-02-10	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)
Attain StarFix Lead Medtronic, Inc Cleared 2026-02-10 Registered with US (FDA)	Medtronic, Inc	2026-02-10	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)
NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) Medtronic Xomed Cleared 2026-02-10 Registered with US (FDA)	Medtronic Xomed	2026-02-10	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)
Vulcan Spinal System K2M, Inc Cleared 2026-02-10 Registered with US (FDA)	K2M, Inc	2026-02-10	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)
Solidex® Ti-Links and Screws CreoDent Hudson Valley Cleared 2026-02-10 Registered with US (FDA)	CreoDent Hudson Valley	2026-02-10	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)
Earflo (EF001) Earflo, Inc. Cleared 2026-02-10 Registered with US (FDA)	Earflo, Inc.	2026-02-10	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)
Holter ECG and ABP system (HolterABP) Edan Instruments, Inc Cleared 2026-02-09 Registered with US (FDA)	Edan Instruments, Inc	2026-02-09	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)
Peel-Away Introducer Sheath VascuTech Medical, LLC Cleared 2026-02-09 Registered with US (FDA)	VascuTech Medical, LLC	2026-02-09	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)
Ceribell Instant EEG Headset Ceribell, Inc. Cleared 2026-02-09 Registered with US (FDA)	Ceribell, Inc.	2026-02-09	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)
Q Interbody Instruments K2M, Inc Cleared 2026-02-06 Registered with US (FDA)	K2M, Inc	2026-02-06	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)
INTEGRE LIO Quantel Medical Cleared 2026-02-06 Registered with US (FDA)	Quantel Medical	2026-02-06	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)
Stainless Steel Surgical Kits Dentsply Sirona Cleared 2026-02-06 Registered with US (FDA)	Dentsply Sirona	2026-02-06	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)
Dermatrix Duo Shenzhen Gsd Technology Co., Ltd. Cleared 2026-02-06 Registered with US (FDA)	Shenzhen Gsd Technology Co., Ltd.	2026-02-06	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)
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) Eieling Technology (Shenzhen) Limited Cleared 2026-02-06 Registered with US (FDA)	Eieling Technology (Shenzhen) Limited	2026-02-06	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)
SIGNA™ Bolt Ge Medical Systems, Inc. Cleared 2026-02-06 Registered with US (FDA)	Ge Medical Systems, Inc.	2026-02-06	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)
ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) Spectranetics Corp. Cleared 2026-02-06 Registered with US (FDA)	Spectranetics Corp.	2026-02-06	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)
IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) Philips Medizin Systeme Boeblingen GmbH Cleared 2026-02-06 Registered with US (FDA)	Philips Medizin Systeme Boeblingen GmbH	2026-02-06	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)
Athelas Home ATHELAS INC. Cleared 2026-02-06 Registered with US (FDA)	ATHELAS INC.	2026-02-06	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)
Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR FUJIFILM Corporation Cleared 2026-02-06 Registered with US (FDA)	FUJIFILM Corporation	2026-02-06	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)
Amferia Wound Dressing Amferia AB Cleared 2026-02-06 Registered with US (FDA)	Amferia AB	2026-02-06	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)
ROSA Knee System with UltraSound Imaging Platform (USIP) Balmoral Medical, LLC Cleared 2026-02-06 Registered with US (FDA)	Balmoral Medical, LLC	2026-02-06	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)
Kneevoice Cartilage Evaluation System (750-3600-001) Kneevoice, Inc. Cleared 2026-02-06 Registered with US (FDA)	Kneevoice, Inc.	2026-02-06	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)
Median LCS (internal name) / eyonis LCS (trade name) (1.0) Median Technologies Cleared 2026-02-06 Registered with US (FDA)	Median Technologies	2026-02-06	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)
Spectra S1 Pro; Spectra S2 Pro Uzinmedicare Co. Cleared 2026-02-06 Registered with US (FDA)	Uzinmedicare Co.	2026-02-06	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)
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture ETHICON LLC Cleared 2026-02-06 Registered with US (FDA)	ETHICON LLC	2026-02-06	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)
SafeBeat Rx App Safebeat Rx, Inc. Cleared 2026-02-06 Registered with US (FDA)	Safebeat Rx, Inc.	2026-02-06	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)
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories Stryker Leibinger Cleared 2026-02-06 Registered with US (FDA)	Stryker Leibinger	2026-02-06	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)
Aptiva APS IgA Reagent Inova Diagnostics, Inc. Cleared 2026-02-06 Registered with US (FDA)	Inova Diagnostics, Inc.	2026-02-06	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)
Atellica® IM TSH3-Ultra II (TSH3ULII) Siemens Healthcare Diagnostics Cleared 2026-02-06 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Siemens Healthcare Diagnostics	2026-02-06	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
LiveMedica Enterprise PACS Live Medica, LLC Cleared 2026-02-06 Registered with US (FDA)	Live Medica, LLC	2026-02-06	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)
LAIA XR Augmented Reality Software S.L. Cleared 2026-02-06 Registered with US (FDA) EU (EUDAMED)	Augmented Reality Software S.L.	2026-02-06	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Primevision 3D Dentsply Sirona Cleared 2026-02-05 Registered with US (FDA)	Dentsply Sirona	2026-02-05	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)
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister Argon Medical Devices, Inc. Cleared 2026-02-05 Registered with US (FDA)	Argon Medical Devices, Inc.	2026-02-05	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)
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Penumbra, Inc. Cleared 2026-02-05 Registered with US (FDA)	Penumbra, Inc.	2026-02-05	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)
SIGNA™ Sprint Select Ge Medical Systems, Inc. Cleared 2026-02-05 Registered with US (FDA)	Ge Medical Systems, Inc.	2026-02-05	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)