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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
Atellica IM HBc Total 2 (HBcT2)

Siemens Healthcare Diagnostics

Cleared 2025-10-17

Registered with
  • US (FDA)
JOVS Electric Stimulation Beauty Device (JE2)

Shenzhen Qianyu Technology Co., Ltd.

Cleared 2025-10-17

Registered with
  • US (FDA)
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)

Siemens Healthcare Diagnostics

Cleared 2025-10-17

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC

Beckman Coulter, Inc.

Cleared 2025-10-17

Registered with
  • US (FDA)
  • AU (TGA)
ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS

Siemens Healthcare Diagnostics

Cleared 2025-10-17

Registered with
  • US (FDA)
Adin Customized Abutments

Adin Dental Implant Systems Ltd

Cleared 2025-10-17

Registered with
  • US (FDA)
Estremo Fibular Nail

Citieffe

Cleared 2025-10-17

Registered with
  • US (FDA)
SureAx-Guide™

Sureax Medical, LLC

Cleared 2025-10-17

Registered with
  • US (FDA)
MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

Shenzhen Zhenxing Ruitong Technology Co., Ltd.

Cleared 2025-10-17

Registered with
  • US (FDA)
ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL

Siemens Healthcare Diagnostics

Cleared 2025-10-17

Registered with
  • US (FDA)
  • AU (TGA)
Modius Lean

Neurovalens , Ltd.

Cleared 2025-10-17

Registered with
  • US (FDA)
IntelliVue Patient monitors MX400, MX450, MX500, MX550

Philips Medizin Systeme Boeblingen GmbH

Cleared 2025-10-17

Registered with
  • US (FDA)
X1-FFR

Spectrawave, Inc.

Cleared 2025-10-17

Registered with
  • US (FDA)
Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

Olympus Medical Systems Corporation

Cleared 2025-10-17

Registered with
  • US (FDA)
Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

The Binding Site Group Limited

Cleared 2025-10-17

Registered with
  • US (FDA)
InZone IST Detachment System; IZDS Connecting Cable

STRYKER NEUROVASCULAR

Cleared 2025-10-17

Registered with
  • US (FDA)
cobas® HBV

Roche Molecular Systems, Inc.

Cleared 2025-10-17

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Alinity m HBV Assay

Abbott Molecular, Inc.

Cleared 2025-10-17

Registered with
  • US (FDA)
S.I.N. Dental Implant System

SIN IMPLANT SYSTEM LTDA

Cleared 2025-10-17

Registered with
  • US (FDA)
MOSkin Radiation Measurement System

Electrogenics Labs, Ltd.

Cleared 2025-10-17

Registered with
  • US (FDA)
X9 Ultrasound System

X9, Inc.

Cleared 2025-10-17

Registered with
  • US (FDA)
ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material

SIEMENS AG

Cleared 2025-10-17

Registered with
  • US (FDA)
EPT-1000 CARDIAC ABLATION SYSTEM

Boston Scientific Corp

Cleared 2025-10-17

Registered with
  • US (FDA)
ADVIA Centaur Anti-Thyroid Peroxidase II

Siemens Healthcare Diagnostics

Cleared 2025-10-17

Registered with
  • US (FDA)
Osteotomy Wedge System

Sinaptic Surgical

Cleared 2025-10-17

Registered with
  • US (FDA)
CARDIAC ABLATION CATHETERS

Boston Scientific Corp

Cleared 2025-10-17

Registered with
  • US (FDA)
  • AU (TGA)
Biopsy Port Adapter

Endosound, Inc.

Cleared 2025-10-17

Registered with
  • US (FDA)
MateLaser Medical Diode Laser Systems (ML-DLS-30)

Matelaser, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
SurgiAid Collagen Wound Dressing (HA)

Maxigen Biotech, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)

Olympus Medical Systems Corporation

Cleared 2025-10-16

Registered with
  • US (FDA)
INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing

Penumbra, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
CryoFreeze Wart and Skin Tag Remover

CRYOSURGERY, INC.

Cleared 2025-10-16

Registered with
  • US (FDA)
Profoject™ Disposable Needle

Cmt Health Pte., Ltd.

Cleared 2025-10-16

Registered with
  • US (FDA)
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Brainlab SE

Cleared 2025-10-16

Registered with
  • US (FDA)
Alpha Endo Handpiece (Alpha Endo)

SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

Cleared 2025-10-16

Registered with
  • US (FDA)
Coolfase

Asterasys Co., Ltd.

Cleared 2025-10-16

Registered with
  • US (FDA)
Uterine Aspiration Set

Gcmedica Enterprise Ltd.(Wuxi)

Cleared 2025-10-16

Registered with
  • US (FDA)
Arthrex Synergy Vision Imaging System

Arthrex, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
EUFLEXXA

Ferring Pharmaceuticals, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
ProZip Knotless Implant

Riverpoint Medical

Cleared 2025-10-16

Registered with
  • US (FDA)
Elos Accurate Hybrid Base

Elos Medtech Pinol A/S

Cleared 2025-10-16

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Re:Balans

Mode Sensors AS

Cleared 2025-10-16

Registered with
  • US (FDA)
Light Therapy Mask (1019055)

Merchsource, LLC

Cleared 2025-10-16

Registered with
  • US (FDA)
NeurAxis IB-Stim (01-1020)

Neuraxis

Cleared 2025-10-16

Registered with
  • US (FDA)
TargetCool™ (RM-DT02W)

Recensmedical, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
SYNGO, CT DUAL ENERGY

Siemens Medical Solutions USA, Inc.

Cleared 2025-10-15

Registered with
  • US (FDA)
TargetCool-e

Recensmedical, Inc.

Cleared 2025-10-15

Registered with
  • US (FDA)
  • EU (EUDAMED)
V-soft Line™ Barbed Surgical Suture (Various)

Feeltech Co., Ltd.

Cleared 2025-10-15

Registered with
  • US (FDA)
BioBrace® Extra-Articular Ligament Augmentation Kit

Conmed Corporation

Cleared 2025-10-15

Registered with
  • US (FDA)
ELEOS™ Limb Salvage System with NanoCept® Technology

Onkos Surgical, Inc

Cleared 2025-10-15

Registered with
  • US (FDA)