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
PyloPlus Urea Breath Test System Arj Medical, Inc. Cleared 2026-02-05 Registered with US (FDA)	Arj Medical, 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)
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)
E3D™-C Interbody System Evolution Spine, LLC Cleared 2026-02-04 Registered with US (FDA) AU (TGA)	Evolution Spine, LLC	2026-02-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not 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)
MENTOR MEMORYSHAPE BREAST IMPLANTS Mentor Worldwide, LLC Cleared 2026-02-04 Registered with US (FDA)	Mentor Worldwide, LLC	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)
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)
SmartGuard technology; Predictive Low Glucose technology Medtronic Minimed Cleared 2026-02-03 Registered with US (FDA)	Medtronic Minimed	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 Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071 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)
Redermax Antibacterial Wound Matrix Beijing Kreate Medical Co., Ltd. Cleared 2026-02-02 Registered with US (FDA)	Beijing Kreate Medical 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)
BIORES Dental Implant System Chengdu Besmile Medical Technology Co., Ltd. Cleared 2026-02-02 Registered with US (FDA)	Chengdu Besmile Medical Technology 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)
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) Merit Medical Ireland, Ltd. Cleared 2026-01-31 Registered with US (FDA)	Merit Medical Ireland, Ltd.	2026-01-31	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)
Clungene RSV Antigen Rapid Test Hangzhou Clongene Biotech Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Hangzhou Clongene Biotech Co., Ltd.	2026-01-30	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)
Disposable Distal End Tape Hood Shanghai SeeGen Photoelectric Technology Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Shanghai SeeGen Photoelectric Technology Co., Ltd.	2026-01-30	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)
RevealAI-Lung Precision Medical Ventures Inc dba RevealDx Cleared 2026-01-30 Registered with US (FDA) UK (MHRA)	Precision Medical Ventures Inc dba RevealDx	2026-01-30	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) Shenzhen Peninsula Medical Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Shenzhen Peninsula Medical Co., Ltd.	2026-01-30	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)
BruxZir® Shaded 16 PLUS Prismatik Dentalcraft, Inc. Cleared 2026-01-30 Registered with US (FDA)	Prismatik Dentalcraft, Inc.	2026-01-30	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)
Boston PICO (Boston PICO) Boston Aesthetics, Inc. Cleared 2026-01-30 Registered with US (FDA)	Boston Aesthetics, Inc.	2026-01-30	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)
SQUID Liquid Embolic Agent (LEA) Balt USA, LLC Cleared 2026-01-30 Registered with US (FDA)	Balt USA, LLC	2026-01-30	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)
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) Asistan Medikal Cleared 2026-01-30 Registered with US (FDA)	Asistan Medikal	2026-01-30	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)
BAROguard Donor Lung Preservation System Paragonix Technologies, Inc. Cleared 2026-01-30 Registered with US (FDA)	Paragonix Technologies, Inc.	2026-01-30	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)
Eluvia Drug-Eluting Vascular Stent System Boston Scientific Corp Cleared 2026-01-30 Registered with US (FDA)	Boston Scientific Corp	2026-01-30	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)
Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) Shenzhen Jianchao Intelligent Technology Co., Ltd. Cleared 2026-01-30 Registered with US (FDA)	Shenzhen Jianchao Intelligent Technology Co., Ltd.	2026-01-30	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)
Dual Stage Venous Cannulae Sorin Group Italia S.R.L. Cleared 2026-01-30 Registered with US (FDA)	Sorin Group Italia S.R.L.	2026-01-30	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)
Motor Handpiece and Control Unit (SDI10) SAESHIN PRECISION CO.,LTD. Cleared 2026-01-30 Registered with US (FDA)	SAESHIN PRECISION CO.,LTD.	2026-01-30	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)
Electric Scooter (Mojo-T580) Dongguan Smarfody Mobility Technology CO, LTD Cleared 2026-01-29 Registered with US (FDA)	Dongguan Smarfody Mobility Technology CO, LTD	2026-01-29	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 Scooter (DDF100) Zhejiang Nysin Medical Co., Ltd. Cleared 2026-01-29 Registered with US (FDA)	Zhejiang Nysin Medical Co., Ltd.	2026-01-29	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)
Multi-Unit DAS System Talladium Espana, SL Cleared 2026-01-29 Registered with US (FDA)	Talladium Espana, SL	2026-01-29	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)
Manual Wheelchair (W50) Jiangsu Jumao X-Care Medical Equipment Co.,Ltd Cleared 2026-01-29 Registered with US (FDA)	Jiangsu Jumao X-Care Medical Equipment Co.,Ltd	2026-01-29	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)
Labcorp Fentanyl Urine Visual Test Medtox Diagnostics, Inc. Cleared 2026-01-29 Registered with US (FDA)	Medtox Diagnostics, Inc.	2026-01-29	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)
EK MULTI ANGLED 30 ABUTMENT Hiossen, Inc. Cleared 2026-01-29 Registered with US (FDA)	Hiossen, Inc.	2026-01-29	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)
Medical Shaver System (Morcellator) (YSB-IIIA) Hangzhou Hawk Optical Electronic Instruments Co.,Ltd. Cleared 2026-01-29 Registered with US (FDA)	Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.	2026-01-29	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)
ACTIVL ARTIFICIAL DISC Highridge Medical LLC Cleared 2026-01-29 Registered with US (FDA)	Highridge Medical LLC	2026-01-29	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)
Neurophet AQUA AD Plus Neurophet., Inc. Cleared 2026-01-29 Registered with US (FDA)	Neurophet., Inc.	2026-01-29	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)
EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits HR HealthCare Cleared 2026-01-29 Registered with US (FDA)	HR HealthCare	2026-01-29	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)
Surgical Reality Viewer MedicalVR BV Cleared 2026-01-29 Registered with US (FDA)	MedicalVR BV	2026-01-29	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)