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
Guided Aarhus Applicator Set Varian Medical Systems inc Cleared 2025-11-19 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Varian Medical Systems inc	2025-11-19	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun Fisher &Paykel Healthcare , Ltd. Cleared 2025-11-19 Registered with US (FDA)	Fisher &Paykel Healthcare , Ltd.	2025-11-19	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)
IPL Hair Removal Device (SYL001AZ, SYL002AZ) Gu'An Yeolight Smart Electronics Co., Ltd. Cleared 2025-11-19 Registered with US (FDA)	Gu'An Yeolight Smart Electronics Co., Ltd.	2025-11-19	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)
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) Ulrich GmbH & Co. KG Cleared 2025-11-18 Registered with US (FDA)	Ulrich GmbH & Co. KG	2025-11-18	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)
Collagen Dura Regeneration Membrane - Repair Collagen Matrix, Inc. Cleared 2025-11-18 Registered with US (FDA)	Collagen Matrix, Inc.	2025-11-18	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)
ToeJack MIS Bunion System Nvision Biomedical Technologies, LLC Cleared 2025-11-18 Registered with US (FDA)	Nvision Biomedical Technologies, LLC	2025-11-18	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 Smart Basal Dexcom, Inc. Cleared 2025-11-18 Registered with US (FDA)	Dexcom, Inc.	2025-11-18	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)
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx Guangzhou Wondfo Biotech Co, Ltd Cleared 2025-11-18 Registered with US (FDA)	Guangzhou Wondfo Biotech Co, Ltd	2025-11-18	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)
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems Prismatik Dentalcraft, Inc. Cleared 2025-11-18 Registered with US (FDA)	Prismatik Dentalcraft, Inc.	2025-11-18	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)
Miniature Telescope for Urology (27033AA) Karl Storz SE & CO.KG Cleared 2025-11-18 Registered with US (FDA)	Karl Storz SE & CO.KG	2025-11-18	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)
Fluido Compact System The Surgical Company International B.V. Cleared 2025-11-18 Registered with US (FDA)	The Surgical Company International B.V.	2025-11-18	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)
Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) Unimed Medical Supplies, Inc. Cleared 2025-11-18 Registered with US (FDA)	Unimed Medical Supplies, Inc.	2025-11-18	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)
Universal Spinal System Double Medical Technology Inc Cleared 2025-11-18 Registered with US (FDA)	Double Medical Technology Inc	2025-11-18	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)
Hexoskin Medical System (7100-00016) Carre Technologies, Inc. Cleared 2025-11-18 Registered with US (FDA)	Carre Technologies, Inc.	2025-11-18	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)
LifeStyles® HydraFeel Natural Rubber Latex Condom Suretex, Ltd. Cleared 2025-11-18 Registered with US (FDA)	Suretex, Ltd.	2025-11-18	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)
Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) Unimed Medical Supplies, Inc. Cleared 2025-11-18 Registered with US (FDA)	Unimed Medical Supplies, Inc.	2025-11-18	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)
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Mercator Medical (Thailand), Ltd. Cleared 2025-11-17 Registered with US (FDA)	Mercator Medical (Thailand), Ltd.	2025-11-17	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)
TS-RF Generator (STS10) Starmed Co., Ltd. Cleared 2025-11-17 Registered with US (FDA)	Starmed Co., Ltd.	2025-11-17	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)
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Cleared 2025-11-17 Registered with US (FDA)	Siemens Medical Solutions USA, Inc.	2025-11-17	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 Rubella IgG Beckman Coulter, Inc. Cleared 2025-11-17 Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Beckman Coulter, Inc.	2025-11-17	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
DeepRESP Nox Medical Ehf Cleared 2025-11-17 Registered with US (FDA)	Nox Medical Ehf	2025-11-17	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)
DTX Studio Assist Nobel Biocare C/O Medicim NV Cleared 2025-11-17 Registered with US (FDA)	Nobel Biocare C/O Medicim NV	2025-11-17	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)
PM2™ System with ECGuide™ Connector Piccolo Medical, Inc. Cleared 2025-11-17 Registered with US (FDA)	Piccolo Medical, Inc.	2025-11-17	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)
AutoDensity Eos Imaging Cleared 2025-11-14 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Eos Imaging	2025-11-14	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Neurolyser XR (NXR100) Fusmobile, Inc. Cleared 2025-11-14 Registered with US (FDA)	Fusmobile, Inc.	2025-11-14	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)
Status™ COVID-19/Flu A&B Princeton Biomeditech Corp Cleared 2025-11-14 Registered with US (FDA)	Princeton Biomeditech Corp	2025-11-14	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)
ARC-EX System Onward Medical, Inc. Cleared 2025-11-14 Registered with US (FDA)	Onward Medical, Inc.	2025-11-14	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)
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) Alovea Healthcare Co. , Ltd. Cleared 2025-11-14 Registered with US (FDA)	Alovea Healthcare Co. , Ltd.	2025-11-14	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)
KLS Martin IPS Forearm System KLS Martin SE & Co KG Cleared 2025-11-14 Registered with US (FDA)	KLS Martin SE & Co KG	2025-11-14	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)
Lyme-ID IgG Test; Bio-ID800 Inanovate, Inc. Cleared 2025-11-14 Registered with US (FDA)	Inanovate, Inc.	2025-11-14	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)
AquaC UNO H Fresenius Medical Care Renal Therapies Group, LLC Cleared 2025-11-14 Registered with US (FDA)	Fresenius Medical Care Renal Therapies Group, LLC	2025-11-14	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)
Second Opinion® Panoramic Pearl, Inc. Cleared 2025-11-14 Registered with US (FDA)	Pearl, Inc.	2025-11-14	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)
Mesh Nebulizer (H6) Qingdao Future Medical Technology Co., Ltd. Cleared 2025-11-14 Registered with US (FDA)	Qingdao Future Medical Technology Co., Ltd.	2025-11-14	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)
Sterilization Trays Paragon Implant Mfg., LLC Cleared 2025-11-14 Registered with US (FDA)	Paragon Implant Mfg., LLC	2025-11-14	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)
Biomoneta Avata Rx Biomoneta Research Private Limited Cleared 2025-11-14 Registered with US (FDA)	Biomoneta Research Private Limited	2025-11-14	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)
System Sophi This AG Cleared 2025-11-14 Registered with US (FDA)	This AG	2025-11-14	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)
Dental Computed Tomography X-ray System Fussen Technology Co,Ltd Cleared 2025-11-13 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Fussen Technology Co,Ltd	2025-11-13	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
LED Beauty Mask (RLBXX) Atop Lighting Co., Ltd. Cleared 2025-11-13 Registered with US (FDA)	Atop Lighting Co., Ltd.	2025-11-13	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)
Geminus Volar Distal Radius Plating System Skeletal Dynamics, LLC Cleared 2025-11-13 Registered with US (FDA)	Skeletal Dynamics, LLC	2025-11-13	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)
ROSA Knee System Orthosoft Inc (D/B/A Zimmer Cas) Cleared 2025-11-13 Registered with US (FDA)	Orthosoft Inc (D/B/A Zimmer Cas)	2025-11-13	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)
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Cleared 2025-11-13 Registered with US (FDA)	Siemens Medical Solutions USA, Inc.	2025-11-13	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)
Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) Shenzhen Future Electronic Co., Ltd. Cleared 2025-11-13 Registered with US (FDA)	Shenzhen Future Electronic Co., Ltd.	2025-11-13	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)
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS Baxter Healthcare Corp Cleared 2025-11-13 Registered with US (FDA) AU (TGA)	Baxter Healthcare Corp	2025-11-13	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
TELLTALE Electrosurgical Guidewire System Telltale, LLC Cleared 2025-11-13 Registered with US (FDA)	Telltale, LLC	2025-11-13	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)
WRISTAR MultiAx Distal Radius Kit Intrauma S.p.A. Cleared 2025-11-12 Registered with US (FDA)	Intrauma S.p.A.	2025-11-12	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)
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) Olympus Medical Systems Corporation Cleared 2025-11-12 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-11-12	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)
Synthes Patient Specific Implants SYNTHES GMBH Cleared 2025-11-12 Registered with US (FDA)	SYNTHES GMBH	2025-11-12	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)
XSTAT P15 Revmedx, Inc. Cleared 2025-11-12 Registered with US (FDA)	Revmedx, Inc.	2025-11-12	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)
EMPOWR Acetabular® Liner Extension Encore Medical LP Cleared 2025-11-12 Registered with US (FDA)	Encore Medical LP	2025-11-12	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)
Powered Wheelchair (PL001-9001) Suzhou KD Intelligent Device Co., Ltd. Cleared 2025-11-12 Registered with US (FDA)	Suzhou KD Intelligent Device Co., Ltd.	2025-11-12	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)