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
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)
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)
Atellica IM TSH3-Ultra II (TSH3ULII) Siemens Healthcare Diagnostics Cleared 2026-02-06 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Siemens Healthcare Diagnostics	2026-02-06	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	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)
Aptiva® APS IgA Reagent Inova Diagnostics, Inc. Cleared 2026-02-06 Registered with US (FDA) EU (EUDAMED)	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)	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)
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)
PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer ARJ Medical LLC Cleared 2026-02-05 Registered with US (FDA)	ARJ Medical LLC	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)
Encora X1 Encora, Inc. Cleared 2026-02-05 Registered with US (FDA)	Encora, 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)
G7® Revision Acetabular System Zimmer Inc Cleared 2026-02-04 Registered with US (FDA) EU (EUDAMED)	Zimmer Inc	2026-02-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
UltraScore Focused Force PTA Balloon Bard Peripheral Vascular Inc Cleared 2026-02-04 Registered with US (FDA) UK (MHRA)	Bard Peripheral Vascular Inc	2026-02-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Henan Yadu Level 4 Surgical Gowns (Reinforced) YADU Medical (Henan) Co, Ltd Cleared 2026-02-04 Registered with US (FDA)	YADU Medical (Henan) Co, Ltd	2026-02-04	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® Ti Interbody Fusion System Spinal Elements, Inc. Cleared 2026-02-04 Registered with US (FDA)	Spinal Elements, Inc.	2026-02-04	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)
ZSmile System Dror Orthodesign Cleared 2026-02-03 Registered with US (FDA)	Dror Orthodesign	2026-02-03	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)
Diagnostic X-Ray Equipment Model POCT22 Ningbo Runyes Medical Instrument Co., Ltd. Cleared 2026-02-03 Registered with US (FDA)	Ningbo Runyes Medical Instrument Co., Ltd.	2026-02-03	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)
Aptima HPV-GT Assay Gen-Probe, Inc. Cleared 2026-02-03 Registered with US (FDA)	Gen-Probe, Inc.	2026-02-03	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)
T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System Stryker Corp. Cleared 2026-02-03 Registered with US (FDA)	Stryker Corp.	2026-02-03	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)
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System Dexcom, Inc. Cleared 2026-02-03 Registered with US (FDA)	Dexcom, Inc.	2026-02-03	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)
APTIMA HPV ASSAY Gen-Probe, Inc. Cleared 2026-02-03 Registered with US (FDA)	Gen-Probe, Inc.	2026-02-03	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)
MSS - Monobloc stem Medacta International S.A. Cleared 2026-02-03 Registered with US (FDA)	Medacta International S.A.	2026-02-03	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)
Explant Express Applied Medical Technology, Inc Cleared 2026-02-03 Registered with US (FDA) UK (MHRA)	Applied Medical Technology, Inc	2026-02-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
808nm semiconductor laser hair removal machine Xi'An Taibo Electronic Technology Co., Ltd. Cleared 2026-02-03 Registered with US (FDA)	Xi'An Taibo Electronic Technology Co., Ltd.	2026-02-03	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)
Navigation Module of the Cortium® System Ulrich Medical USA Cleared 2026-02-03 Registered with US (FDA)	Ulrich Medical USA	2026-02-03	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)
HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) Philips Medical Systems, Inc. Cleared 2026-02-02 Registered with US (FDA)	Philips Medical Systems, Inc.	2026-02-02	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)
CHIKAI Nexus petit Asahi Intecc Co., Ltd. Cleared 2026-02-02 Registered with US (FDA)	Asahi Intecc Co., Ltd.	2026-02-02	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)
Vital Signs Oxehealth Limited Cleared 2026-02-02 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Oxehealth Limited	2026-02-02	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
TAP2D Nano-X Imaging , Ltd. Cleared 2026-02-02 Registered with US (FDA)	Nano-X Imaging , Ltd.	2026-02-02	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)