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.

3,689 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
Picasso Pro Diode Laser (002-00460) CAO Group, Inc. Cleared 2026-03-11 Registered with US (FDA)	CAO Group, Inc.	2026-03-11	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)
Strut Suture; No-Tie Button Riverpoint Medical Cleared 2026-03-11 Registered with US (FDA)	Riverpoint Medical	2026-03-11	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)
Straumann® BLC Implants - Indication Widening Institut Straumann AG Cleared 2026-03-10 Registered with US (FDA)	Institut Straumann AG	2026-03-10	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)
Sonosite iLOOK Ultrasound System Fujifilm Sonosite Inc Cleared 2026-03-10 Registered with US (FDA) UK (MHRA)	Fujifilm Sonosite Inc	2026-03-10	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Gemini NOVA 810+980 Soft Tissue Laser Azena Medical, LLC Cleared 2026-03-10 Registered with US (FDA)	Azena Medical, LLC	2026-03-10	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)
Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System Cardiovascular Systems Incorporated Cleared 2026-03-10 Registered with US (FDA)	Cardiovascular Systems Incorporated	2026-03-10	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)
MyChoice CDx Myriad Genetic Laboratories Cleared 2026-03-10 Registered with US (FDA)	Myriad Genetic Laboratories	2026-03-10	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)
IPS e.max Zirconia Ivoclar Vivadent AG Cleared 2026-03-10 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Ivoclar Vivadent AG	2026-03-10	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Reselute Tibial Nail Reselute, Inc. Cleared 2026-03-10 Registered with US (FDA)	Reselute, Inc.	2026-03-10	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)
myray ProXIma X6 Cefla S.C. Cleared 2026-03-10 Registered with US (FDA)	Cefla S.C.	2026-03-10	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)
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE Boston Scientific Corp Cleared 2026-03-10 Registered with US (FDA)	Boston Scientific Corp	2026-03-10	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)
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) Canon Medical Systems Corporation Cleared 2026-03-10 Registered with US (FDA)	Canon Medical Systems Corporation	2026-03-10	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)
DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System SYNTHES GMBH Cleared 2026-03-10 Registered with US (FDA)	SYNTHES GMBH	2026-03-10	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)
Varios Combi Pro2 NAKANISHI INC. Cleared 2026-03-10 Registered with US (FDA)	NAKANISHI INC.	2026-03-10	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)
Medicell Mycosis Laser (MCML24004) Medicell Healthcare Co.,LTD Cleared 2026-03-09 Registered with US (FDA)	Medicell Healthcare Co.,LTD	2026-03-09	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)
LiverMultiScan (v6.0) Perspectum Ltd Cleared 2026-03-09 Registered with US (FDA)	Perspectum Ltd	2026-03-09	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)
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B QIAGEN GmbH Cleared 2026-03-09 Registered with US (FDA)	QIAGEN GmbH	2026-03-09	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)
NeoSculpt Plus S&M Medical Co., Ltd. Cleared 2026-03-09 Registered with US (FDA)	S&M Medical Co., Ltd.	2026-03-09	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)
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) Shenzhen Root Innovation Technology Co., Ltd. Cleared 2026-03-09 Registered with US (FDA)	Shenzhen Root Innovation Technology Co., Ltd.	2026-03-09	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)
GORE TAG Thoracic Endoprosthesis W. L. Gore and Associates, Inc. Cleared 2026-03-09 Registered with US (FDA)	W. L. Gore and Associates, Inc.	2026-03-09	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)
DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System SYNTHES GMBH Cleared 2026-03-09 Registered with US (FDA)	SYNTHES GMBH	2026-03-09	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)
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) Zimmer Inc Cleared 2026-03-09 Registered with US (FDA)	Zimmer Inc	2026-03-09	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)
Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup WEBEST Biotech,, LLC Cleared 2026-03-09 Registered with US (FDA)	WEBEST Biotech,, LLC	2026-03-09	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)
FiberTape Button Arthrex, Inc. Cleared 2026-03-09 Registered with US (FDA)	Arthrex, Inc.	2026-03-09	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)
FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 FUJIFILM Corporation Cleared 2026-03-09 Registered with US (FDA)	FUJIFILM Corporation	2026-03-09	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)
Onera SleepMap (SLEEPMAP) Onera B.V. Cleared 2026-03-08 Registered with US (FDA)	Onera B.V.	2026-03-08	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)
CVAC Image Processor Calyxo, Inc. Cleared 2026-03-06 Registered with US (FDA)	Calyxo, 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)
JFord Speculum Sleeve™ Ford Medtech, LLC Cleared 2026-03-06 Registered with US (FDA)	Ford Medtech, LLC	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)
VELYS™ Hip Navigation Depuy Ireland UC Cleared 2026-03-06 Registered with US (FDA)	Depuy Ireland UC	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)
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 TMJ RECONSTRUCTION PROSTHESIS SYSTEM 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)
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)	Nanosonics Limited	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)
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)
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)