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
IMMULITE® 2000 Anti-HBs Siemens Healthcare Diagnostics Products Limited Cleared 2025-09-18 Registered with US (FDA) UK (MHRA)	Siemens Healthcare Diagnostics Products Limited	2025-09-18	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Normatec Elite Hip Normatec Industries, LP Cleared 2025-09-18 Registered with US (FDA)	Normatec Industries, LP	2025-09-18	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)
Magic InBra Medela, Inc. Cleared 2025-09-18 Registered with US (FDA) Canada (Health Canada)	Medela, Inc.	2025-09-18	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Axial3D Insight Axial Medical Printing Limited Cleared 2025-09-18 Registered with US (FDA)	Axial Medical Printing Limited	2025-09-18	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)
InnerView System Perimetrics, Inc. Cleared 2025-09-18 Registered with US (FDA) AU (TGA)	Perimetrics, Inc.	2025-09-18	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Sunny Plus (Sunny) ShenB Co., Ltd. Cleared 2025-09-18 Registered with US (FDA)	ShenB Co., Ltd.	2025-09-18	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)
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) Mobarn Medical Devices, LLC Cleared 2025-09-18 Registered with US (FDA)	Mobarn Medical Devices, LLC	2025-09-18	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)
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) Olympus Medical Systems Corporation Cleared 2025-09-18 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-09-18	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)
Electric Wheelchair (Model P2) Superpi Robot Co., Ltd. Cleared 2025-09-18 Registered with US (FDA)	Superpi Robot Co., Ltd.	2025-09-18	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)
IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit' Siemens Healthcare Diagnostics Products Limited Cleared 2025-09-18 Registered with US (FDA)	Siemens Healthcare Diagnostics Products Limited	2025-09-18	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)
Ruthless Spine RJB Ruthless, LLC Dba Ruthless Spine Cleared 2025-09-17 Registered with US (FDA)	Ruthless, LLC Dba Ruthless Spine	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)
Trident®, ABC® Howmedica Osteonics Corp. Cleared 2025-09-17 Registered with US (FDA)	Howmedica Osteonics Corp.	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)
Double Tube Herbst Appliance The Tmj Clinic PC Cleared 2025-09-17 Registered with US (FDA)	The Tmj Clinic PC	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)
PlasmaFlow X Compression Sleeve Device (XPF0001) Manamed, Inc. Cleared 2025-09-17 Registered with US (FDA)	Manamed, 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)
MarginProbe System Dilon Medical Technologies, Ltd. Cleared 2025-09-17 Registered with US (FDA)	Dilon Medical Technologies, Ltd.	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)
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses Pegavision Corporation Cleared 2025-09-17 Registered with US (FDA)	Pegavision 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)
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) Shenzhen Yicai Health Technology Co., Ltd. Cleared 2025-09-17 Registered with US (FDA)	Shenzhen Yicai Health Technology Co., Ltd.	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)
ECHELON Synergy FUJIFILM Corporation Cleared 2025-09-17 Registered with US (FDA)	FUJIFILM 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)
Carpentier-Edwards Physio Annuloplasty Ring (4450) Edwards Lifesciences, LLC Cleared 2025-09-17 Registered with US (FDA)	Edwards Lifesciences, LLC	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)
DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) Kamemizu Chemical Industry Co., Ltd. Cleared 2025-09-17 Registered with US (FDA)	Kamemizu Chemical Industry Co., Ltd.	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)
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)
InferOperate Suite Beijing Infervision Healthcare Medical Technology Co., Ltd. Cleared 2025-09-15 Registered with US (FDA)	Beijing Infervision Healthcare Medical Technology 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)
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)
CloudTMS Edge Teleemg, LLC Cleared 2025-09-14 Registered with US (FDA)	Teleemg, LLC	2025-09-14	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)
Vertex(TM) Catheter Jupiter Endovascular Cleared 2025-09-12 Registered with US (FDA)	Jupiter Endovascular	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)
Compact II Enraf-Nonius, B.V. Cleared 2025-09-12 Registered with US (FDA)	Enraf-Nonius, B.V.	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)
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup VivaChek Biotech (Hangzhou) Co, Ltd Cleared 2025-09-12 Registered with US (FDA)	VivaChek Biotech (Hangzhou) 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)
BONX805 BONTECH Co., Ltd. Cleared 2025-09-12 Registered with US (FDA)	BONTECH 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)
bite away two Mibetec, GmbH Cleared 2025-09-12 Registered with US (FDA) UK (MHRA)	Mibetec, GmbH	2025-09-12	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Legend X Platform Pollogen, Ltd. Cleared 2025-09-12 Registered with US (FDA)	Pollogen, 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)
BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) Becton Dickinson and Company Cleared 2025-09-12 Registered with US (FDA)	Becton Dickinson and Company	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)
LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) Boston Scientific Corp Cleared 2025-09-12 Registered with US (FDA)	Boston Scientific Corp	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)
Stethophone Pro Sparrow Acoustics, Inc. Cleared 2025-09-12 Registered with US (FDA)	Sparrow Acoustics, 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)
Erchonia EVRL ERCHONIA CORPORATION Cleared 2025-09-12 Registered with US (FDA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	ERCHONIA CORPORATION	2025-09-12	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
ViewMateTM Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cleared 2025-09-12 Registered with US (FDA)	Shenzhen Mindray Bio-Medical Electronics 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)
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller Tangent Endoscopy, LLC Cleared 2025-09-12 Registered with US (FDA)	Tangent Endoscopy, LLC	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)
Fast Warm - NX Fujifilm Irvine Scientific, Inc. Cleared 2025-09-12 Registered with US (FDA)	Fujifilm Irvine Scientific, 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)
Spine & Trauma Navigation Instruments Brainlab SE Cleared 2025-09-12 Registered with US (FDA)	Brainlab SE	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)