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
PuraStat 3-D MATRIX EUROPE SAS Cleared 2026-01-07 Registered with US (FDA) Canada (Health Canada) AU (TGA)	3-D MATRIX EUROPE SAS	2026-01-07	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) MEDTRONIC SOFAMOR DANEK USA, INC. Cleared 2026-01-07 Registered with US (FDA)	MEDTRONIC SOFAMOR DANEK USA, INC.	2026-01-07	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)
Clear Aligner (SCF-3348) Beame Medical Technology (Shenzhen) Limited Cleared 2026-01-07 Registered with US (FDA)	Beame Medical Technology (Shenzhen) Limited	2026-01-07	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)
VyBrate™ VBR System Vy Spine, LLC Cleared 2026-01-07 Registered with US (FDA)	Vy Spine, LLC	2026-01-07	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)
Sangria™ Thrombectomy System Avantec Vascular Corp. Cleared 2026-01-07 Registered with US (FDA)	Avantec Vascular Corp.	2026-01-07	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)
Neodent InLab Validated Workflow Jjgc Industria E Comercio DE Materiais Dentarios S.A. Cleared 2026-01-07 Registered with US (FDA)	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	2026-01-07	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)
ZenSeal Pro KERR CORPORATION Cleared 2026-01-07 Registered with US (FDA)	KERR CORPORATION	2026-01-07	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)
BriefCase-Triage: CARE Multi-triage CT Body Aidoc Medical , Ltd. Cleared 2026-01-07 Registered with US (FDA)	Aidoc Medical , Ltd.	2026-01-07	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)
DeltaWave Nasal Pillow System Remsleep Holdings Cleared 2026-01-07 Registered with US (FDA)	Remsleep Holdings	2026-01-07	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)
Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC Cleared 2026-01-07 Registered with US (FDA)	Innovative Health, LLC	2026-01-07	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)
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models Materialise N.V Cleared 2026-01-07 Registered with US (FDA)	Materialise N.V	2026-01-07	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)
LOGIQ Fortis GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Cleared 2026-01-07 Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	2026-01-07	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)
aprevo® cervical interbody system Carlsmed, Inc. Cleared 2026-01-06 Registered with US (FDA)	Carlsmed, Inc.	2026-01-06	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 Needle Hh Global Technology, Inc. Cleared 2026-01-06 Registered with US (FDA)	Hh Global Technology, Inc.	2026-01-06	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)
Sensilift Pro (ST300XXYYZZZ) El Global Trade, Ltd. Cleared 2026-01-06 Registered with US (FDA)	El Global Trade, Ltd.	2026-01-06	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)
Saans (F4-01-00-000-000) Innaccel Technologies Private Limited Cleared 2026-01-06 Registered with US (FDA)	Innaccel Technologies Private Limited	2026-01-06	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)
Materialise TKA Guide System Materialise N.V Cleared 2026-01-06 Registered with US (FDA)	Materialise N.V	2026-01-06	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)
VENTANA anti-MSH6 (SP93) Antibody Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) Cleared 2026-01-06 Registered with US (FDA)	Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)	2026-01-06	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)
QuadLock™ Fixation System ABANZA TECNOMED, S.L. Cleared 2026-01-06 Registered with US (FDA)	ABANZA TECNOMED, S.L.	2026-01-06	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)
TriLEAP Plating System Crossroads Extremity Systems, LLC Cleared 2026-01-06 Registered with US (FDA)	Crossroads Extremity Systems, LLC	2026-01-06	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)
VENTANA anti-MSH6 (SP93) Antibody Ventana Medical Systems, Inc. Cleared 2026-01-06 Registered with US (FDA)	Ventana Medical Systems, Inc.	2026-01-06	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)
V-DAC Catheter Vesalio Cleared 2026-01-06 Registered with US (FDA)	Vesalio	2026-01-06	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)
Medconn 8K Glycated Hemoglobin Test System Shanghai Medconn Medical Technology Co.,Ltd. Cleared 2026-01-06 Registered with US (FDA)	Shanghai Medconn Medical Technology Co.,Ltd.	2026-01-06	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)
maiLink Maihub Corp. Cleared 2026-01-05 Registered with US (FDA)	Maihub Corp.	2026-01-05	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)
SurfRider 13 Microcatheter Kaneka Americas Holding, Inc. Cleared 2026-01-05 Registered with US (FDA)	Kaneka Americas Holding, Inc.	2026-01-05	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)
ORBERA INTRAGASTRIC BALLOON Boston Scientific Corp Cleared 2026-01-05 Registered with US (FDA)	Boston Scientific Corp	2026-01-05	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)
Disposable Medical Face Mask Makrite Industries, Inc. Cleared 2026-01-05 Registered with US (FDA) EU (EUDAMED)	Makrite Industries, Inc.	2026-01-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
On-X Prosthetic Heart Valve On-X Life Technologies, Inc. Cleared 2026-01-05 Registered with US (FDA) EU (EUDAMED)	On-X Life Technologies, Inc.	2026-01-05	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Atellica IM Total PSA II (tPSAII) Siemens Healthcare Diagnostics Cleared 2026-01-05 Registered with US (FDA)	Siemens Healthcare Diagnostics	2026-01-05	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)
Puracyn® Plus Antimicrobial Irrigation Solution INNOVACYN, INC. Cleared 2026-01-05 Registered with US (FDA)	INNOVACYN, INC.	2026-01-05	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)
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Cleared 2026-01-05 Registered with US (FDA)	Samsung Medison Co., Ltd.	2026-01-05	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)
ChartCheck (RADCH V1.6) Radformation Cleared 2026-01-05 Registered with US (FDA)	Radformation	2026-01-05	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)
MAGiC Ablation Catheter Stereotaxis, Inc. Cleared 2026-01-05 Registered with US (FDA)	Stereotaxis, Inc.	2026-01-05	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)
MONTAGE XT Cranial Cement Orthocon, LLC Cleared 2026-01-02 Registered with US (FDA)	Orthocon, LLC	2026-01-02	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)
Ready to use Nelaton Catheter Jamjoom Fullcare Corporation Cleared 2026-01-02 Registered with US (FDA)	Jamjoom Fullcare Corporation	2026-01-02	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)
FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit ZuriMED Technologies AG Cleared 2026-01-02 Registered with US (FDA)	ZuriMED Technologies AG	2026-01-02	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)
Mobility Scooter (BC-MS310) Ningbo Baichen Medical Devices Co., Ltd. Cleared 2026-01-02 Registered with US (FDA)	Ningbo Baichen Medical Devices Co., Ltd.	2026-01-02	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)
Bulkamid Urethral Bulking System Boston Scientific Corp Cleared 2026-01-02 Registered with US (FDA)	Boston Scientific Corp	2026-01-02	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)
Genesis Sleep Neurofield, Inc. Cleared 2025-12-31 Registered with US (FDA)	Neurofield, Inc.	2025-12-31	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)
ASCENSION MCP Smith & Nephew, Inc. Cleared 2025-12-31 Registered with US (FDA)	Smith & Nephew, Inc.	2025-12-31	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)
MOLLI 2 System Stryker Endoscopy Cleared 2025-12-31 Registered with US (FDA)	Stryker Endoscopy	2025-12-31	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)
Proliv™Rx System Neurolief , Ltd. Cleared 2025-12-31 Registered with US (FDA)	Neurolief , Ltd.	2025-12-31	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)
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) Arc Trauma, LLC Cleared 2025-12-31 Registered with US (FDA)	Arc Trauma, LLC	2025-12-31	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)
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) Shenzhen Jiantuo Electronics Co., Ltd. Cleared 2025-12-31 Registered with US (FDA)	Shenzhen Jiantuo Electronics Co., Ltd.	2025-12-31	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)
Lipids Truvian Health Cleared 2025-12-30 Registered with US (FDA)	Truvian Health	2025-12-30	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)
AnyScan 3.0 NM Scanner Family Mediso Medical Imaging Systems Ltd Cleared 2025-12-30 Registered with US (FDA)	Mediso Medical Imaging Systems Ltd	2025-12-30	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)
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer Lucas Lifecare Cleared 2025-12-30 Registered with US (FDA)	Lucas Lifecare	2025-12-30	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)
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm Arthrex, Inc. Cleared 2025-12-30 Registered with US (FDA)	Arthrex, Inc.	2025-12-30	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)
TruSPECT Processing Station Spectrum Dynamics Medical, Ltd. Cleared 2025-12-30 Registered with US (FDA)	Spectrum Dynamics Medical, Ltd.	2025-12-30	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)
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) TECHNO-PATH MANUFACTURING LTD. Cleared 2025-12-30 Registered with US (FDA)	TECHNO-PATH MANUFACTURING LTD.	2025-12-30	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)