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
Velocity Alpha MR High Speed Surgical Drill System Adeor Medical AG Cleared 2026-03-06 Registered with US (FDA)	Adeor Medical AG	2026-03-06	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)
BONTREE PLUS Hudens Bio Co., Ltd. Cleared 2026-03-06 Registered with US (FDA)	Hudens Bio Co., Ltd.	2026-03-06	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)
TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st Stryker Leibinger Cleared 2026-03-06 Registered with US (FDA)	Stryker Leibinger	2026-03-06	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)
EXOGEN Ultrasound Bone Healing System Bioventus, LLC Cleared 2026-03-06 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Bioventus, LLC	2026-03-06	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Bunkerhill Contrast AVC Bunkerhill Health Cleared 2026-03-06 Registered with US (FDA)	Bunkerhill Health	2026-03-06	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)
Single use stone retrieval balloons Zhejiang Chuangxiang Medical Technology Co., Ltd. Cleared 2026-03-06 Registered with US (FDA)	Zhejiang Chuangxiang Medical Technology Co., Ltd.	2026-03-06	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)
TeKBrace Knotless Anchor Theramicro Cleared 2026-03-06 Registered with US (FDA)	Theramicro	2026-03-06	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)
Water-based lubricant Guangzhou Haoyimai Trading Co., Ltd. Cleared 2026-03-06 Registered with US (FDA)	Guangzhou Haoyimai Trading Co., Ltd.	2026-03-06	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)
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR Olympus Medical Systems Corporation Cleared 2026-03-06 Registered with US (FDA)	Olympus Medical Systems Corporation	2026-03-06	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)
Bunkerhill Contrast CAC Bunkerhill Health Cleared 2026-03-06 Registered with US (FDA)	Bunkerhill Health	2026-03-06	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)
Treace Medical Concepts (TMC) Screw Fixation System Treace Medical Concepts, Inc. Cleared 2026-03-06 Registered with US (FDA)	Treace Medical Concepts, Inc.	2026-03-06	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)
EmeryGlide™ (EG18008901) Nano4imaging GmbH Cleared 2026-03-06 Registered with US (FDA)	Nano4imaging GmbH	2026-03-06	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)
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Cleared 2026-03-06 Registered with US (FDA)	Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.	2026-03-06	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)
Magnifico Open (100009900) Esaote, S.P.A. Cleared 2026-03-05 Registered with US (FDA)	Esaote, S.P.A.	2026-03-05	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)
AV Cardiac CT Philips Medical Systems Nederland BV Cleared 2026-03-05 Registered with US (FDA)	Philips Medical Systems Nederland BV	2026-03-05	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)
CORIS System Nanosonics Limited Cleared 2026-03-05 Registered with US (FDA) AU (TGA)	Nanosonics Limited	2026-03-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Extension tube Zhuhai DR Medical Instruments Co., Ltd. Cleared 2026-03-05 Registered with US (FDA)	Zhuhai DR Medical Instruments Co., Ltd.	2026-03-05	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)
Adhese 2 Ivoclar Vivadent AG Cleared 2026-03-05 Registered with US (FDA) UK (MHRA)	Ivoclar Vivadent AG	2026-03-05	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Rapid fFN for the TLiIQ System Hologic Inc Cleared 2026-03-05 Registered with US (FDA)	Hologic Inc	2026-03-05	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)
Phantom® Hindfoot TTC/TC Nail System Paragon 28, Inc Cleared 2026-03-05 Registered with US (FDA) AU (TGA)	Paragon 28, Inc	2026-03-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Arthrex FibuLock Nail System Arthrex, Inc. Cleared 2026-03-05 Registered with US (FDA)	Arthrex, Inc.	2026-03-05	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)
YUWELL® Electronic Blood Pressure Monitor (YE630CR) Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. Cleared 2026-03-05 Registered with US (FDA)	Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.	2026-03-05	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)
EarliPoint Assessment Earlitec Diagnostics, Inc. Cleared 2026-03-05 Registered with US (FDA)	Earlitec Diagnostics, Inc.	2026-03-05	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)
CEPHX3D Orca Dental AI , Ltd. Cleared 2026-03-05 Registered with US (FDA)	Orca Dental AI , Ltd.	2026-03-05	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)
QT Scanner 2000 Model A Qt Imaging, Inc. Cleared 2026-03-04 Registered with US (FDA)	Qt Imaging, Inc.	2026-03-04	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)
SureSmile Software Dentsply Sirona Cleared 2026-03-04 Registered with US (FDA)	Dentsply Sirona	2026-03-04	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)
Oncomine Dx Target Test Life Technologies Holdings Pte Ltd Cleared 2026-03-04 Registered with US (FDA) UK (MHRA)	Life Technologies Holdings Pte Ltd	2026-03-04	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Klär Lite (RCW-KL1000) Radcliffe Watts, LLC Cleared 2026-03-04 Registered with US (FDA)	Radcliffe Watts, LLC	2026-03-04	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)
The EVO/EVO+ Visian Implantable Collamer Lens (ICL) Staar Surgical Co. Cleared 2026-03-04 Registered with US (FDA)	Staar Surgical Co.	2026-03-04	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)
ANTERIS Thoracolumbar Plate System Spinecraft, Inc. Cleared 2026-03-04 Registered with US (FDA)	Spinecraft, Inc.	2026-03-04	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)
LifeVac Lifevac, LLC Cleared 2026-03-04 Registered with US (FDA)	Lifevac, LLC	2026-03-04	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)
Aevumed FENIX Suture Anchor Aevumed, Inc. Cleared 2026-03-04 Registered with US (FDA)	Aevumed, Inc.	2026-03-04	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)
Mendit Escala Medical Cleared 2026-03-04 Registered with US (FDA)	Escala Medical	2026-03-04	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)
TENS/EMS device (GUSE01) Globalcare Medical Technology Co, Ltd Cleared 2026-03-04 Registered with US (FDA)	Globalcare Medical Technology Co, Ltd	2026-03-04	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)
Electric Wheelchair (MP148) Suzhou Master Machinery Manufacturing Co.,Ltd Cleared 2026-03-04 Registered with US (FDA)	Suzhou Master Machinery Manufacturing Co.,Ltd	2026-03-04	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)
KS Healing Abutment Osstem Implant Co., Ltd. Cleared 2026-03-04 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Osstem Implant Co., Ltd.	2026-03-04	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char Devicor Medical Products, Inc. Cleared 2026-03-04 Registered with US (FDA)	Devicor Medical Products, Inc.	2026-03-04	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)
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class Element Science, Inc. Cleared 2026-03-04 Registered with US (FDA)	Element Science, Inc.	2026-03-04	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)
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2026-03-04 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2026-03-04	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)
Dentis SQ-SL AXEL Fixture Dentis Co., Ltd. Cleared 2026-03-04 Registered with US (FDA)	Dentis Co., Ltd.	2026-03-04	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)
SenTiva™ Generator, SenTiva Duo™ Generator LivaNova USA Inc Cleared 2026-03-04 Registered with US (FDA)	LivaNova USA Inc	2026-03-04	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)
Active Intramedullary (AIM) Tibial Nail System Satori Orthopaedics, Inc. Cleared 2026-03-04 Registered with US (FDA)	Satori Orthopaedics, Inc.	2026-03-04	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)
LED Therapy Light (COB1400, HP1800PRO) Shenzhen Hanhua Opto Co., Ltd. Cleared 2026-03-03 Registered with US (FDA)	Shenzhen Hanhua Opto Co., Ltd.	2026-03-03	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)
Surgical Face Mask (Ear mount) Zhejiang Hangkang Medical Equipment Co., Ltd. Cleared 2026-03-03 Registered with US (FDA)	Zhejiang Hangkang Medical Equipment Co., Ltd.	2026-03-03	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)
Mosaic Neo Mitral Bioprosthesis Medtronic, Inc Cleared 2026-03-03 Registered with US (FDA) UK (MHRA) AU (TGA)	Medtronic, Inc	2026-03-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Annalise Enterprise Harrison-AI Medical Pty Ltd Cleared 2026-03-03 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Harrison-AI Medical Pty Ltd	2026-03-03	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
SOTA Cloud Smart Sensor (1.5) Sota Cloud Corp. Cleared 2026-03-03 Registered with US (FDA)	Sota Cloud Corp.	2026-03-03	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)
PathLoc Lumbar Plate System L&K BIOMED CO., LTD Cleared 2026-03-03 Registered with US (FDA)	L&K BIOMED CO., LTD	2026-03-03	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)
CO2 Laser Treatment Machine (CFR3M1) Haidari Beauty Technology (Beijing) Co., , Ltd. Cleared 2026-03-03 Registered with US (FDA)	Haidari Beauty Technology (Beijing) Co., , Ltd.	2026-03-03	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)
ZAFIRA® NEW STETIC S.A. Cleared 2026-03-03 Registered with US (FDA)	NEW STETIC S.A.	2026-03-03	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)