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
Momcozy Wearable Breast Pump (BP223) Shenzhen Root Innovation Technology Co., Ltd. Cleared 2025-09-08 Registered with US (FDA)	Shenzhen Root Innovation 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)
OmniTom Elite with PCD Neurologica Corporation Cleared 2025-09-08 Registered with US (FDA)	Neurologica Corporation	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)
MAXXOS P.A.C.E. Foot & Ankle Plating System Maxxos Medical GmbH Cleared 2025-09-08 Registered with US (FDA)	Maxxos Medical 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)
Straumann Emdogain Straumann USA Cleared 2025-09-05 Registered with US (FDA)	Straumann USA	2025-09-05	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)
pREBOA-PRO Catheter Prytime Medical Devices, Inc. Cleared 2025-09-05 Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Prytime Medical Devices, Inc.	2025-09-05	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cleared 2025-09-05 Registered with US (FDA)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2025-09-05	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 Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL THERMO FISHER SCIENTIFIC INC. Cleared 2025-09-05 Registered with US (FDA)	THERMO FISHER SCIENTIFIC INC.	2025-09-05	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)
GenaCheck COVID-19 Rapid Self-Test Genabio Diagnostics, Inc. Cleared 2025-09-05 Registered with US (FDA)	Genabio Diagnostics, Inc.	2025-09-05	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)
WatchPAT400 (WP400) Itamar Medical Cleared 2025-09-05 Registered with US (FDA)	Itamar Medical	2025-09-05	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)
Ureteral Access Sheath Zhejiang YiGao Medical Technology Co, Ltd Cleared 2025-09-05 Registered with US (FDA) Canada (Health Canada) AU (TGA)	Zhejiang YiGao Medical Technology Co, Ltd	2025-09-05	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
High Pressure Tubing Shandong Int Medical Instruments Co., Ltd. Cleared 2025-09-05 Registered with US (FDA)	Shandong Int Medical Instruments Co., Ltd.	2025-09-05	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)
SOLOPASS 2.0 System Intravent Medical Partners, LP Cleared 2025-09-05 Registered with US (FDA)	Intravent Medical Partners, LP	2025-09-05	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)
3D-SHAPER 3D-Shaper Medical S.L. Cleared 2025-09-05 Registered with US (FDA) EU (EUDAMED)	3D-Shaper Medical S.L.	2025-09-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
All-Suture Dual Anchor System Suturetech, Inc. Cleared 2025-09-05 Registered with US (FDA)	Suturetech, Inc.	2025-09-05	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)
Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port Bard Access Systems, Inc. Cleared 2025-09-05 Registered with US (FDA)	Bard Access Systems, Inc.	2025-09-05	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)
LIBERTY Endovascular Robotic System (LIBERTYOS) Microbot Medical , Ltd. Cleared 2025-09-04 Registered with US (FDA)	Microbot Medical , Ltd.	2025-09-04	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)
Careverse CoronaryDoc (Careverse CoronaryDoc) Careverse Technology Pte. , Ltd. Cleared 2025-09-04 Registered with US (FDA)	Careverse Technology Pte. , Ltd.	2025-09-04	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)
Rapid Obstructive Hydrocephalus, Rapid OH Ischemaview, Inc. Cleared 2025-09-04 Registered with US (FDA)	Ischemaview, Inc.	2025-09-04	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)
Endoskeleton™ Interbody Systems MEDTRONIC SOFAMOR DANEK USA, INC. Cleared 2025-09-04 Registered with US (FDA)	MEDTRONIC SOFAMOR DANEK USA, INC.	2025-09-04	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)
EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) Abbott Medical Cleared 2025-09-04 Registered with US (FDA)	Abbott Medical	2025-09-04	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)
Ball Joint Guide Array (66295) Bayer Medical Care Inc Cleared 2025-09-04 Registered with US (FDA)	Bayer Medical Care Inc	2025-09-04	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)
Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) Clinical Laserthermia Systems AB Cleared 2025-09-04 Registered with US (FDA)	Clinical Laserthermia Systems AB	2025-09-04	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)
KALA MINI 2.0 (KALA-04) SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. Cleared 2025-09-04 Registered with US (FDA)	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.	2025-09-04	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)
NextAR(TM) Shoulder Platform Medacta International S.A. Cleared 2025-09-04 Registered with US (FDA)	Medacta International S.A.	2025-09-04	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)
Lutonix Drug Coated Balloon PTA Catheter Lutonix Cleared 2025-09-04 Registered with US (FDA) AU (TGA)	Lutonix	2025-09-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Image Suite Carestream Health, Inc. Cleared 2025-09-04 Registered with US (FDA)	Carestream Health, Inc.	2025-09-04	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® AirGuard System The Surgical Company International BV (As Tsc Life) Cleared 2025-09-04 Registered with US (FDA)	The Surgical Company International BV (As Tsc Life)	2025-09-04	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)
Intense Pulsed Light Therapy Device (MMABM-1) Micowey Medical Equipment (Guangxi) Co., Ltd. Cleared 2025-09-04 Registered with US (FDA)	Micowey Medical Equipment (Guangxi) Co., Ltd.	2025-09-04	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)
Optina-4C (MHRC-C1N) Optina Diagnostics Cleared 2025-09-04 Registered with US (FDA)	Optina Diagnostics	2025-09-04	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)
CINtec PLUS Cytology Ventana Medical Systems, Inc. Cleared 2025-09-04 Registered with US (FDA)	Ventana Medical Systems, Inc.	2025-09-04	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)
Oniris; Oniris Plus Oniris Cleared 2025-09-04 Registered with US (FDA)	Oniris	2025-09-04	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)
Dose+ (1.0) Mvision AI OY Cleared 2025-09-04 Registered with US (FDA)	Mvision AI OY	2025-09-04	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)
Apollo TMS Therapy System Mag & More GmbH Cleared 2025-09-04 Registered with US (FDA) AU (TGA)	Mag & More GmbH	2025-09-04	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) Guilin Woodpecker Medical Instrument Co., Ltd. Cleared 2025-09-04 Registered with US (FDA)	Guilin Woodpecker Medical Instrument Co., Ltd.	2025-09-04	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)
Diode laser therapy device (VADER) Beijing Superlaser Technology Co., Ltd. Cleared 2025-09-03 Registered with US (FDA)	Beijing Superlaser Technology Co., Ltd.	2025-09-03	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)
AViTA Arm Type Blood Pressure Monitor Cuff Avita Corporation Cleared 2025-09-03 Registered with US (FDA)	Avita Corporation	2025-09-03	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)
Tempus Pixel Arterys, Inc. Cleared 2025-09-03 Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	Arterys, Inc.	2025-09-03	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System Alphatec Spine, Inc. Cleared 2025-09-03 Registered with US (FDA)	Alphatec Spine, Inc.	2025-09-03	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)
AGNES Ultra Agnes Medical Co., Ltd. Cleared 2025-09-03 Registered with US (FDA)	Agnes Medical Co., Ltd.	2025-09-03	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)
Kinos Total Ankle System Restor3d Cleared 2025-09-03 Registered with US (FDA)	Restor3d	2025-09-03	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)
MEDILIGHT Medicreations, LLC Cleared 2025-09-03 Registered with US (FDA)	Medicreations, LLC	2025-09-03	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)
Lava Liquid Embolic System (Lava LES) SIRTEX MEDICAL, INC. Cleared 2025-09-03 Registered with US (FDA)	SIRTEX MEDICAL, INC.	2025-09-03	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)
AquaCast Mask Blessing Cathay Corporation Cleared 2025-09-03 Registered with US (FDA)	Blessing Cathay Corporation	2025-09-03	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)
Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) Dongguan E-Test Technology Co., Ltd. Cleared 2025-09-03 Registered with US (FDA)	Dongguan E-Test Technology Co., Ltd.	2025-09-03	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)
NeurotriS (SX2500); NeurotriS (SX3800) A-1 Engineering Cleared 2025-09-03 Registered with US (FDA)	A-1 Engineering	2025-09-03	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)
SignalNED System (Model RE) Forest Devices, Inc. Cleared 2025-09-03 Registered with US (FDA)	Forest Devices, Inc.	2025-09-03	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)
BruxZir NOW Prismatik Dentalcraft, Inc. Cleared 2025-09-03 Registered with US (FDA)	Prismatik Dentalcraft, Inc.	2025-09-03	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)
prodisc® L Centinel Spine Cleared 2025-09-02 Registered with US (FDA) UK (MHRA)	Centinel Spine	2025-09-02	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
OsteoSight™ Hip (v1) Naitive Technologies, Ltd. Cleared 2025-09-02 Registered with US (FDA)	Naitive Technologies, Ltd.	2025-09-02	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)
Aerogen Pro-X1 Controller System Aerogen, Inc. Cleared 2025-09-02 Registered with US (FDA)	Aerogen, Inc.	2025-09-02	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)