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.

3,665 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
The BAG manual resuscitator and accessories Laerdal Medical AS Cleared 2025-11-24 Registered with US (FDA)	Laerdal Medical AS	2025-11-24	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)
KARL STORZ Cholangiography Set Karl Storz SE & CO.KG Cleared 2025-11-22 Registered with US (FDA)	Karl Storz SE & CO.KG	2025-11-22	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)
Ceribell Infant Seizure Detection Software Ceribell, Inc. Cleared 2025-11-21 Registered with US (FDA)	Ceribell, Inc.	2025-11-21	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)
Senographe Pristina 3D Ge Healthcare Cleared 2025-11-21 Registered with US (FDA)	Ge Healthcare	2025-11-21	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)
Nelli (Version 7.11) Neuro Event Labs Oy Cleared 2025-11-21 Registered with US (FDA)	Neuro Event Labs Oy	2025-11-21	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)
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) Staclear, Inc. Cleared 2025-11-21 Registered with US (FDA)	Staclear, Inc.	2025-11-21	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)
FluoroDose Varnish Centrix, Inc. Cleared 2025-11-21 Registered with US (FDA)	Centrix, Inc.	2025-11-21	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)
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory Deroyal Industries, Inc. Cleared 2025-11-21 Registered with US (FDA)	Deroyal Industries, Inc.	2025-11-21	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)
TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) Graphy, Inc. Cleared 2025-11-21 Registered with US (FDA)	Graphy, Inc.	2025-11-21	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)
CardioVision Icardio.Ai Cleared 2025-11-21 Registered with US (FDA)	Icardio.Ai	2025-11-21	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)
BEE HA NGMedical GmbH Cleared 2025-11-21 Registered with US (FDA)	NGMedical GmbH	2025-11-21	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)
EffortMed PEEK Cages & Corpectomy Cages Effortmed, LLC Cleared 2025-11-21 Registered with US (FDA)	Effortmed, LLC	2025-11-21	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)
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants Dentsply Sirona Cleared 2025-11-21 Registered with US (FDA)	Dentsply Sirona	2025-11-21	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)
Articulator Arthroscopic Bur Joint Preservation Innovations, LLC Cleared 2025-11-21 Registered with US (FDA)	Joint Preservation Innovations, LLC	2025-11-21	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)
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 Everyway Medical Instruments Co.,Ltd Cleared 2025-11-21 Registered with US (FDA)	Everyway Medical Instruments Co.,Ltd	2025-11-21	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)
Oxygen Concentrator (J5A) Foshan Kycare Medical Equipment Co., Ltd. Cleared 2025-11-21 Registered with US (FDA)	Foshan Kycare Medical Equipment Co., Ltd.	2025-11-21	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)
LEGACY Phasor Health, LLC Cleared 2025-11-21 Registered with US (FDA)	Phasor Health, LLC	2025-11-21	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)
UVAR PHOTOPHERESIS SYSTEM Therakos Development Limited Cleared 2025-11-21 Registered with US (FDA)	Therakos Development Limited	2025-11-21	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)
Archy Dental Imaging Archy Dental, Inc. Cleared 2025-11-21 Registered with US (FDA)	Archy Dental, Inc.	2025-11-21	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)
Manual Wheelchair (HM305-Air1, HM305-Air2) Suzhou Master Machinery Manufacturing Co.,Ltd Cleared 2025-11-21 Registered with US (FDA)	Suzhou Master Machinery Manufacturing Co.,Ltd	2025-11-21	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 Mobility Scooter (PMS105, GUT177, GCAT047) Intradin (Shanghai) Machinery Co, Ltd Cleared 2025-11-21 Registered with US (FDA)	Intradin (Shanghai) Machinery Co, Ltd	2025-11-21	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)
Pen Injector Needle 32.5 Terumo Corp. Cleared 2025-11-21 Registered with US (FDA) Canada (Health Canada)	Terumo Corp.	2025-11-21	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Cleared 2025-11-20 Registered with US (FDA)	Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.	2025-11-20	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)
UltraPrint-Dental Denture UV GUANGZHOU HEYGEARS IMC.INC Cleared 2025-11-20 Registered with US (FDA)	GUANGZHOU HEYGEARS IMC.INC	2025-11-20	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)
CORUS-LX Implant Providence Medical Technology, Inc. Cleared 2025-11-20 Registered with US (FDA)	Providence Medical Technology, Inc.	2025-11-20	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)
cobas liat Bordetella panel nucleic acid test Roche Molecular Systems, Inc. Cleared 2025-11-20 Registered with US (FDA)	Roche Molecular Systems, Inc.	2025-11-20	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)
PlanOne 1 Cosylab Jsc, Control System Laboratory Cleared 2025-11-20 Registered with US (FDA)	Cosylab Jsc, Control System Laboratory	2025-11-20	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)
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) Medline Industries, Inc. Cleared 2025-11-20 Registered with US (FDA)	Medline Industries, Inc.	2025-11-20	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)
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) Remington Medical, Inc. Cleared 2025-11-20 Registered with US (FDA)	Remington Medical, Inc.	2025-11-20	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 Response Ortho Smart Fixator - Hexapod System Response Ortho Solutions, LLC Cleared 2025-11-20 Registered with US (FDA)	Response Ortho Solutions, LLC	2025-11-20	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)
HardyDisk AST Cefiderocol 30µg (FDC30) Hardy Diagnostics Cleared 2025-11-20 Registered with US (FDA)	Hardy Diagnostics	2025-11-20	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)
TaperSet™ Hip System Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics Cleared 2025-11-20 Registered with US (FDA)	Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics	2025-11-20	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)
OptumSI Implant System Si Solutions, LLC Cleared 2025-11-20 Registered with US (FDA)	Si Solutions, LLC	2025-11-20	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)
CuRAS Hybrid Classys, Inc. Cleared 2025-11-20 Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Classys, Inc.	2025-11-20	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Disposable Polymer Ligation Clips Hangzhou Kangji Medical Instrument Co, Ltd Cleared 2025-11-20 Registered with US (FDA)	Hangzhou Kangji Medical Instrument Co, Ltd	2025-11-20	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)
Nuvis® Wireless HD Camera System (Nuvis-2K) Integrated Endoscopy, Inc. Cleared 2025-11-20 Registered with US (FDA)	Integrated Endoscopy, Inc.	2025-11-20	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)
syngo.MR Applications (VB80) Siemens Healthineers AG Cleared 2025-11-20 Registered with US (FDA)	Siemens Healthineers AG	2025-11-20	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)
IntelliSep test Cytovale, Inc. Cleared 2025-11-19 Registered with US (FDA)	Cytovale, Inc.	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)
Microcurrent Facial Device (CEC101, EEI101) Shenzhen Dachi Communication Co., Ltd. Cleared 2025-11-19 Registered with US (FDA)	Shenzhen Dachi Communication 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)
MyPAO SA guides Medacta International S.A. Cleared 2025-11-19 Registered with US (FDA)	Medacta International S.A.	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)
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) SUNGLOR TECHNOLOGY CO., LTD Cleared 2025-11-19 Registered with US (FDA)	SUNGLOR TECHNOLOGY 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)
FOCAL ONE Edap Technomed, Inc. Cleared 2025-11-19 Registered with US (FDA)	Edap Technomed, Inc.	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)
SternaFuse Ti Fixation System Fusion Innovations, LLC Cleared 2025-11-19 Registered with US (FDA)	Fusion Innovations, LLC	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)
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) Huizhou Foryou Medical Devices Co, Ltd Cleared 2025-11-19 Registered with US (FDA)	Huizhou Foryou Medical Devices 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)
ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors Depuy Ireland UC Cleared 2025-11-19 Registered with US (FDA)	Depuy Ireland UC	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)
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)