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
External Fixation Mini Rail System Paragon 28, Inc Cleared 2025-09-30 Registered with US (FDA)	Paragon 28, Inc	2025-09-30	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)
miDiagnostics HSV-1&2 CSF Test Midiagnostics NV Cleared 2025-09-30 Registered with US (FDA)	Midiagnostics NV	2025-09-30	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)
PALTOP DENTAL IMPLANT SYSTEM Paltop Advanced Dental Solutions, Ltd. Cleared 2025-09-29 Registered with US (FDA)	Paltop Advanced Dental Solutions, Ltd.	2025-09-29	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)
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) Hager & Meisinger GmbH Cleared 2025-09-29 Registered with US (FDA)	Hager & Meisinger GmbH	2025-09-29	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)
SMART PCFD Disior, Ltd. Cleared 2025-09-29 Registered with US (FDA)	Disior, Ltd.	2025-09-29	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)
SureTome™ SW Sphincterotome with DomeTip Wilson-Cook Medical, Inc. Cleared 2025-09-29 Registered with US (FDA) Canada (Health Canada)	Wilson-Cook Medical, Inc.	2025-09-29	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
UltraGuideCTR® image guided soft tissue release system Sonex Health, Inc. Cleared 2025-09-29 Registered with US (FDA)	Sonex Health, Inc.	2025-09-29	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)
G-BLOCK Graphenano Dental S.L. Cleared 2025-09-29 Registered with US (FDA)	Graphenano Dental S.L.	2025-09-29	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)
LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT Bard Peripheral Vascular Inc Cleared 2025-09-29 Registered with US (FDA)	Bard Peripheral Vascular Inc	2025-09-29	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)
Portable oxygen concentrator (JAY-1000P) Longfian Scitech Co., Ltd. Cleared 2025-09-29 Registered with US (FDA)	Longfian Scitech Co., Ltd.	2025-09-29	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)
Primero Safe Access System South53, LLC Cleared 2025-09-29 Registered with US (FDA)	South53, LLC	2025-09-29	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)
SpineAR SNAP (SyncAR Spine) Surgical Theater, LLC Cleared 2025-09-29 Registered with US (FDA)	Surgical Theater, LLC	2025-09-29	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)
NEW DOUBLO 2.0 Hironic Co., Ltd. Cleared 2025-09-29 Registered with US (FDA)	Hironic Co., Ltd.	2025-09-29	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)
allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) Tulavi Therapeutics Cleared 2025-09-29 Registered with US (FDA)	Tulavi Therapeutics	2025-09-29	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)
AUXILIARY WATER TUBE MAJ-855 Olympus Medical Systems Corporation Cleared 2025-09-26 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-09-26	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)
LoFric Origo Wellspect AB Cleared 2025-09-26 Registered with US (FDA)	Wellspect AB	2025-09-26	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)
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS Boston Scientific Corp Cleared 2025-09-26 Registered with US (FDA)	Boston Scientific Corp	2025-09-26	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)
Optima Coil System (Optima Packing Coil System) Balt USA, LLC Cleared 2025-09-26 Registered with US (FDA) AU (TGA)	Balt USA, LLC	2025-09-26	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
FUJIFILM Stiffening Wire Device (SW-2000) Fujifilm Healthcare Americas Corporation Cleared 2025-09-26 Registered with US (FDA)	Fujifilm Healthcare Americas Corporation	2025-09-26	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)
Tuned Self-Fitting Mobile App Tuned , Ltd. Cleared 2025-09-26 Registered with US (FDA)	Tuned , Ltd.	2025-09-26	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)
Magnetic Surgical System Levita Magnetics International Corp Cleared 2025-09-26 Registered with US (FDA)	Levita Magnetics International Corp	2025-09-26	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)
Planmed XFI Planmed OY Cleared 2025-09-26 Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Planmed OY	2025-09-26	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Thulium Laser System (Deluxlase) Nanjing Bestview Laser S&T Co., Ltd. Cleared 2025-09-26 Registered with US (FDA)	Nanjing Bestview Laser S&T Co., Ltd.	2025-09-26	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)
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) Linshom Medical, Inc. Cleared 2025-09-26 Registered with US (FDA)	Linshom Medical, Inc.	2025-09-26	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)
VitalStream ART Connect; VitalStream-Hemo Caretaker Medical, LLC Cleared 2025-09-26 Registered with US (FDA)	Caretaker Medical, LLC	2025-09-26	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)
Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP Canon Medical Systems Corporation Cleared 2025-09-26 Registered with US (FDA)	Canon Medical Systems Corporation	2025-09-26	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)
Auxano® Wedge Fixation System Auxano Medical, LLC Cleared 2025-09-25 Registered with US (FDA)	Auxano Medical, LLC	2025-09-25	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)
Panther Fusion GI Expanded Bacterial Assay Hologic Inc Cleared 2025-09-25 Registered with US (FDA)	Hologic Inc	2025-09-25	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)
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced Covidien Cleared 2025-09-25 Registered with US (FDA)	Covidien	2025-09-25	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)
Endeavor™ Stand-Alone Cervical IBF System INNOVASIS, INC. Cleared 2025-09-25 Registered with US (FDA)	INNOVASIS, INC.	2025-09-25	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 Colistin in the dilution range of 0.12-16 ug/mL THERMO FISHER SCIENTIFIC INC. Cleared 2025-09-25 Registered with US (FDA)	THERMO FISHER SCIENTIFIC INC.	2025-09-25	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)
Steripath® Flow™ Blood Collection System Magnolia Medical Technologies, Inc. Cleared 2025-09-25 Registered with US (FDA)	Magnolia Medical Technologies, Inc.	2025-09-25	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)
Single-Use Biopsy Valve (MAJ-1555) Olympus Medical Systems Corporation Cleared 2025-09-25 Registered with US (FDA)	Olympus Medical Systems Corporation	2025-09-25	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)
Pulse Oximeter Shanghai Berry Electronic Tech Co., Ltd. Cleared 2025-09-25 Registered with US (FDA) UK (MHRA) AU (TGA)	Shanghai Berry Electronic Tech Co., Ltd.	2025-09-25	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Panther Fusion GI Bacterial Assay Hologic Inc Cleared 2025-09-25 Registered with US (FDA)	Hologic Inc	2025-09-25	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)
Essilor® Stellest® Essilor of America, Inc. Cleared 2025-09-25 Registered with US (FDA)	Essilor of America, Inc.	2025-09-25	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)
Stem Extension Line (U2 Total Knee System—PSA Type) United Orthopedic Corporation Cleared 2025-09-25 Registered with US (FDA)	United Orthopedic Corporation	2025-09-25	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)
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer Stryker Instruments Cleared 2025-09-25 Registered with US (FDA)	Stryker Instruments	2025-09-25	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)
JDEvolution Plus L and JDEvolution Plus LE JDentalCare Srl Cleared 2025-09-25 Registered with US (FDA)	JDentalCare Srl	2025-09-25	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)
EMBOTRAP III Revascularization Device NEURAVI LIMITED Cleared 2025-09-25 Registered with US (FDA) Canada (Health Canada)	NEURAVI LIMITED	2025-09-25	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Hi bebe super (BT-150B) Bistos Co., Ltd. Cleared 2025-09-25 Registered with US (FDA)	Bistos Co., Ltd.	2025-09-25	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)
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) Yung Sheng Optical Co, Ltd Cleared 2025-09-25 Registered with US (FDA)	Yung Sheng Optical Co, Ltd	2025-09-25	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)
uMR 680 Shanghai United Imaging Healthcare Co., Ltd. Cleared 2025-09-25 Registered with US (FDA) AU (TGA)	Shanghai United Imaging Healthcare Co., Ltd.	2025-09-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) Wuhan Dimed Laser Technology Co., Ltd. Cleared 2025-09-25 Registered with US (FDA)	Wuhan Dimed Laser Technology Co., Ltd.	2025-09-25	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)
Brain WMH Quantib B.V. Cleared 2025-09-25 Registered with US (FDA)	Quantib B.V.	2025-09-25	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)
Alinity m HCV Abbott Molecular, Inc. Cleared 2025-09-25 Registered with US (FDA) AU (TGA)	Abbott Molecular, Inc.	2025-09-25	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Root canal repair materials (nRoot BP) Enpuno Biotechnology Co., Ltd. Cleared 2025-09-25 Registered with US (FDA)	Enpuno Biotechnology Co., Ltd.	2025-09-25	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)
Resitu Slider 09 (RESL09) Resitu Medical AB Cleared 2025-09-24 Registered with US (FDA)	Resitu Medical AB	2025-09-24	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)
Digital X-Ray DentiMax Pro Imaging System DENTIMAX Cleared 2025-09-24 Registered with US (FDA)	DENTIMAX	2025-09-24	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)
Celerity 20 HP Biological Indicator STERIS SAS Cleared 2025-09-24 Registered with US (FDA)	STERIS SAS	2025-09-24	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)