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.

3,664 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
FG Bone Graft M Full Golden Biotech Corporation Cleared 2025-09-17 Registered with US (FDA)	Full Golden Biotech Corporation	2025-09-17	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)
Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) Abbott GmbH Cleared 2025-09-17 Registered with US (FDA)	Abbott GmbH	2025-09-17	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)
Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) Vitacore Industries, Inc. Cleared 2025-09-17 Registered with US (FDA)	Vitacore Industries, Inc.	2025-09-17	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)
SFIT Abutment Cowellmedi Co., Ltd. Cleared 2025-09-16 Registered with US (FDA)	Cowellmedi Co., Ltd.	2025-09-16	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)
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) Microtek Medical Inc Cleared 2025-09-16 Registered with US (FDA)	Microtek Medical Inc	2025-09-16	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)
Insight Enhanced™ DRF (EN-1002-01) Imaging Engineering, LLC Cleared 2025-09-16 Registered with US (FDA)	Imaging Engineering, LLC	2025-09-16	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)
ACCUJECT Injector Set 2.1-1P (LP604590) Medicel AG Cleared 2025-09-16 Registered with US (FDA)	Medicel AG	2025-09-16	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)
Disposable Prophy Angle (3399-60, 3399-090, 3399-105) Premium Plus (Dongguan) Limited Cleared 2025-09-15 Registered with US (FDA)	Premium Plus (Dongguan) Limited	2025-09-15	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)
Sober Self-Test Sober Ip, LLC Cleared 2025-09-15 Registered with US (FDA)	Sober Ip, LLC	2025-09-15	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)
iGPS Navigation Instruments Si-Bone, Inc. Cleared 2025-09-15 Registered with US (FDA)	Si-Bone, Inc.	2025-09-15	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)
SpaceFix Shoulder Spacer G21 Srl Cleared 2025-09-15 Registered with US (FDA)	G21 Srl	2025-09-15	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 (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) Miley Technology (Hebei) Co., Ltd. Cleared 2025-09-15 Registered with US (FDA)	Miley Technology (Hebei) Co., Ltd.	2025-09-15	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)
Zener® (model ZEN-001-B1) Uvx, Inc. Cleared 2025-09-15 Registered with US (FDA)	Uvx, Inc.	2025-09-15	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)
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) Shanghai AnQing Medical Instrument Co., Ltd. Cleared 2025-09-15 Registered with US (FDA)	Shanghai AnQing Medical Instrument Co., Ltd.	2025-09-15	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)