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
Volta AF-Xplorer II Volta Medical Cleared 2025-09-12 Registered with US (FDA)	Volta Medical	2025-09-12	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)
CADDIE Odin Medical Limited Cleared 2025-09-12 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Odin Medical Limited	2025-09-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
LED Light Therapy Mask (2311, 2344, 2457, 2458) Dongguan Yanxi Technology Co., Ltd. Cleared 2025-09-12 Registered with US (FDA)	Dongguan Yanxi Technology Co., Ltd.	2025-09-12	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)
PowerKnot High Strength Sutures Medacta International S.A. Cleared 2025-09-12 Registered with US (FDA)	Medacta International S.A.	2025-09-12	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)
DynaNail TTC Fusion System MedShape, Inc. Cleared 2025-09-12 Registered with US (FDA)	MedShape, Inc.	2025-09-12	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)
uWS-Angio Shanghai United Imaging Healthcare Co., Ltd. Cleared 2025-09-12 Registered with US (FDA)	Shanghai United Imaging Healthcare Co., Ltd.	2025-09-12	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)
FETOLY Diagnoly Cleared 2025-09-12 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Diagnoly	2025-09-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Hypertension Notification Feature (HTNF) Apple, Inc. Cleared 2025-09-11 Registered with US (FDA) AU (TGA)	Apple, Inc.	2025-09-11	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Vivatmo pro-S Bosch Healthcare Solutions GmbH Cleared 2025-09-11 Registered with US (FDA)	Bosch Healthcare Solutions GmbH	2025-09-11	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)
Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) Augment Intelligent Medical System (China) Co., Ltd. Cleared 2025-09-11 Registered with US (FDA)	Augment Intelligent Medical System (China) Co., Ltd.	2025-09-11	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)
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology Smith & Nephew Medical, Ltd. Cleared 2025-09-11 Registered with US (FDA) Canada (Health Canada)	Smith & Nephew Medical, Ltd.	2025-09-11	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Paradise Ultrasound Renal Denervation System; Paradise™ Catheter Recor Medical, Inc. Cleared 2025-09-11 Registered with US (FDA)	Recor Medical, Inc.	2025-09-11	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)
SEFRIA™ Hydrocodone Oral Fluid Immunalysis Corporation Cleared 2025-09-11 Registered with US (FDA)	Immunalysis Corporation	2025-09-11	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)
Nylon flexTAP(R) Airway Technologies D/B/A Airway Management Cleared 2025-09-11 Registered with US (FDA)	Airway Technologies D/B/A Airway Management	2025-09-11	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)
UV5000 Handle Uroviu Corporation Cleared 2025-09-11 Registered with US (FDA)	Uroviu Corporation	2025-09-11	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)
SIGNA™ Sprint Ge Medical Systems, Inc. Cleared 2025-09-11 Registered with US (FDA)	Ge Medical Systems, Inc.	2025-09-11	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)
XTRA4 AL.CHI.MI.A. S.R.L. Cleared 2025-09-11 Registered with US (FDA)	AL.CHI.MI.A. S.R.L.	2025-09-11	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)
OsteoProbe (OP-100) Active Life Scientific, Inc. Cleared 2025-09-11 Registered with US (FDA)	Active Life Scientific, Inc.	2025-09-11	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)
PowerWire® 14 Radiofrequency Guidewire Kit BAYLIS MEDICAL TECHNOLOGIES INC. Cleared 2025-09-11 Registered with US (FDA)	BAYLIS MEDICAL TECHNOLOGIES INC.	2025-09-11	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)
Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd. Cleared 2025-09-11 Registered with US (FDA) AU (TGA)	Mazor Robotics , Ltd.	2025-09-11	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Serafin® Tns Co., Ltd. Cleared 2025-09-11 Registered with US (FDA)	Tns Co., Ltd.	2025-09-11	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)
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens Vizionfocus, Inc. Cleared 2025-09-10 Registered with US (FDA)	Vizionfocus, Inc.	2025-09-10	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)
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full Fisher &Paykel Healthcare , Ltd. Cleared 2025-09-10 Registered with US (FDA)	Fisher &Paykel Healthcare , Ltd.	2025-09-10	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)
Enlight 2100 (TPL-E2103-0) Timpel SA Cleared 2025-09-10 Registered with US (FDA)	Timpel SA	2025-09-10	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)
FINEVISION HP Trifocal IOLs Beaver-Visitec International Ltd Cleared 2025-09-10 Registered with US (FDA)	Beaver-Visitec International Ltd	2025-09-10	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)
iQ200 Series Beckman Coulter, Inc. Cleared 2025-09-10 Registered with US (FDA)	Beckman Coulter, Inc.	2025-09-10	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)
Surfacer Inside-Out Access Catheter System Merit Medical System, Inc. Cleared 2025-09-10 Registered with US (FDA)	Merit Medical System, Inc.	2025-09-10	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)
OptiLUV Device Pollogen, Ltd. Cleared 2025-09-10 Registered with US (FDA)	Pollogen, Ltd.	2025-09-10	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)
AngioWaveNet Angiowave Imaging, Inc. Cleared 2025-09-10 Registered with US (FDA)	Angiowave Imaging, Inc.	2025-09-10	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)
OptiVu™ Shoulder Mr Surgical Solutions, LLC Cleared 2025-09-10 Registered with US (FDA)	Mr Surgical Solutions, LLC	2025-09-10	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)
AquaA FRESENIUS MEDICAL CARE NORTH AMERICA Cleared 2025-09-09 Registered with US (FDA)	FRESENIUS MEDICAL CARE NORTH AMERICA	2025-09-09	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)
Electric Wheelchair (GY-E001) Shandong Guyue Healthcare Appliance Co., Ltd Cleared 2025-09-09 Registered with US (FDA)	Shandong Guyue Healthcare Appliance Co., Ltd	2025-09-09	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)
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) Shenzhen Yongquan Medical Devices Co., Ltd. Cleared 2025-09-09 Registered with US (FDA)	Shenzhen Yongquan Medical Devices Co., Ltd.	2025-09-09	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)
Edema Guard Monitor (EGM) CardioSet-001 Cardioset Medical , Ltd. Cleared 2025-09-09 Registered with US (FDA)	Cardioset Medical , Ltd.	2025-09-09	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)
Quadsense (Quadsense and Quadsense Pro) Eventum Orthopaedics Ltd Cleared 2025-09-09 Registered with US (FDA)	Eventum Orthopaedics Ltd	2025-09-09	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)
Segmentron Viewer Dgnct, LLC Cleared 2025-09-09 Registered with US (FDA)	Dgnct, LLC	2025-09-09	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)
Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) Fresenius Medical Care Renal Therapies Group, LLC Cleared 2025-09-09 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2025-09-09	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)
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation Stryker Instruments Cleared 2025-09-09 Registered with US (FDA)	Stryker Instruments	2025-09-09	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)
MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test Guangzhou Decheng Biotechnology Co., Ltd. Cleared 2025-09-09 Registered with US (FDA)	Guangzhou Decheng Biotechnology Co., Ltd.	2025-09-09	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)
Hybrid Viewer (00859873006240) Hermes Medical Solutions AB Cleared 2025-09-09 Registered with US (FDA)	Hermes Medical Solutions AB	2025-09-09	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)
Access anti-HAV Beckman Coulter, Inc. Cleared 2025-09-09 Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Beckman Coulter, Inc.	2025-09-09	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
AI-Rad Companion Prostate MR Siemens Healthcare GmbH Cleared 2025-09-09 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Siemens Healthcare GmbH	2025-09-09	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
MuscleView 2.0 Springbok, Inc. (Dba Springbok Analytics) Cleared 2025-09-09 Registered with US (FDA)	Springbok, Inc. (Dba Springbok Analytics)	2025-09-09	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)
COAPTIUM Connect with TISSIUM LIGHT Tissium SA Cleared 2025-09-08 Registered with US (FDA)	Tissium SA	2025-09-08	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)
DUO Microcatheter Rev Neuro, LLC Cleared 2025-09-08 Registered with US (FDA)	Rev Neuro, LLC	2025-09-08	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)
saypha® MagIQ™ Croma-Pharma GmbH Cleared 2025-09-08 Registered with US (FDA)	Croma-Pharma GmbH	2025-09-08	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)
BioTraceIO Vision (V1.7) Techsomed Medical Technologies , Ltd. Cleared 2025-09-08 Registered with US (FDA)	Techsomed Medical Technologies , Ltd.	2025-09-08	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)
Dual Action Tissue Closure Device Micro-Tech (Nanjing) Co., Ltd . Cleared 2025-09-08 Registered with US (FDA) UK (MHRA)	Micro-Tech (Nanjing) Co., Ltd .	2025-09-08	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
qER-CTA (v1.0) Qure.Ai Technologies Cleared 2025-09-08 Registered with US (FDA)	Qure.Ai Technologies	2025-09-08	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)
Wearable Breast Pump (Model S33) SHENZHEN TPH TECHNOLOGY CO., LTD. Cleared 2025-09-08 Registered with US (FDA)	SHENZHEN TPH TECHNOLOGY CO., LTD.	2025-09-08	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)