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
RESTYLANE INJECTABLE GEL Q-Med AB Cleared 2026-03-12 Registered with US (FDA)	Q-Med AB	2026-03-12	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)
Deep Capsule® (Deep Capsule US) Digestaid - Artificial Intelligence Development SA Cleared 2026-03-12 Registered with US (FDA)	Digestaid - Artificial Intelligence Development SA	2026-03-12	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)
Liv Pre-lubricated Intermittent Catheter HR HealthCare Cleared 2026-03-12 Registered with US (FDA)	HR HealthCare	2026-03-12	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)
Tyto Stethoscope (G3) Tyto Care , Ltd. Cleared 2026-03-12 Registered with US (FDA)	Tyto Care , Ltd.	2026-03-12	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)
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) A Cute Baby, Inc. Cleared 2026-03-12 Registered with US (FDA)	A Cute Baby, Inc.	2026-03-12	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)
Urocross Expander System (Model Numbers ES2018 and ES3025) Prodeon Medical, Inc. Cleared 2026-03-12 Registered with US (FDA)	Prodeon Medical, Inc.	2026-03-12	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)
Taurus Clip Taurus Endoscopy Cleared 2026-03-12 Registered with US (FDA)	Taurus Endoscopy	2026-03-12	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)
Zionic Pro Max (EMS) Termosalud, S.L. Cleared 2026-03-12 Registered with US (FDA)	Termosalud, S.L.	2026-03-12	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)
Tigertriever 25 Revascularization Device Rapid-Medical , Ltd. Cleared 2026-03-12 Registered with US (FDA) EU (EUDAMED)	Rapid-Medical , Ltd.	2026-03-12	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Precision7; Precision7 for Astigmatism; Precision7 Multifocal Alcon Laboratories Cleared 2026-03-11 Registered with US (FDA)	Alcon Laboratories	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)
INHANCE™ Reverse Shoulder System Depuy Ireland UC Cleared 2026-03-11 Registered with US (FDA)	Depuy Ireland UC	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)
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System Carestream Health, Inc. Cleared 2026-03-11 Registered with US (FDA)	Carestream Health, 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)
da Vinci Force Feedback Instruments Intuitive Surgical, Inc. Cleared 2026-03-11 Registered with US (FDA)	Intuitive Surgical, 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)
Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One Kulzer, LLC Cleared 2026-03-11 Registered with US (FDA)	Kulzer, LLC	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)
Xpert Hand Newclip Technics S.A.S Cleared 2026-03-11 Registered with US (FDA)	Newclip Technics S.A.S	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)
Venous Return Cannulae LivaNova USA Inc Cleared 2026-03-11 Registered with US (FDA)	LivaNova USA 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)
LUOFUCON® Antimicrobial Wound Gel Huizhou Foryou Medical Co., Ltd. Cleared 2026-03-11 Registered with US (FDA)	Huizhou Foryou Medical Co., Ltd.	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)
Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) Shenzhen Chuangtong Yigou Technology Co., Ltd. Cleared 2026-03-11 Registered with US (FDA)	Shenzhen Chuangtong Yigou Technology Co., Ltd.	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)
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)
Astron Pulsar Pulsar-18, Pulsar-18 T3 Biotronik, GmbH & Co. Cleared 2026-03-10 Registered with US (FDA)	Biotronik, GmbH & Co.	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)	Fujifilm Sonosite 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)
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)
Astron Biotronik, GmbH & Co. Cleared 2026-03-10 Registered with US (FDA)	Biotronik, GmbH & Co.	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® Conformable 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)
GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System W. L. Gore and Associates, Inc. Cleared 2026-03-09 Registered with US (FDA) UK (MHRA) AU (TGA)	W. L. Gore and Associates, Inc.	2026-03-09	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	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)