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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.

3,400 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)

Livsmed, Inc.

Cleared 2025-10-21

Registered with
  • US (FDA)
brAIn™ Shoulder Positioning

Avatar Medical

Cleared 2025-10-20

Registered with
  • US (FDA)
Q-Switched Nd: YAG Laser machine (LFS-C13U)

Sanhe Lefis Electronics Co., Ltd.

Cleared 2025-10-20

Registered with
  • US (FDA)
A8 INTEGR8™ Porous Pedicle Screws

Allumin8, Inc.

Cleared 2025-10-20

Registered with
  • US (FDA)
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)

Vascular Flow Technologies, Ltd.

Cleared 2025-10-20

Registered with
  • US (FDA)
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)

Feeltech Co., Ltd.

Cleared 2025-10-20

Registered with
  • US (FDA)
InkSpace Imaging Small Body Array (SBA12PH30x)

Inkspace Imaging, Inc.

Cleared 2025-10-20

Registered with
  • US (FDA)
VereSee Optical Veres Needle and Endoscopic Camera

Freyja Healthcare, LLC

Cleared 2025-10-20

Registered with
  • US (FDA)
AVAVA™ Skin Treatment System

Avava, Inc.

Cleared 2025-10-20

Registered with
  • US (FDA)
Remi Custom Night Guard

Remi

Cleared 2025-10-17

Registered with
  • US (FDA)
StealthStation S8 Spine Software

Medtronic Navigation Inc

Cleared 2025-10-17

Registered with
  • US (FDA)
  • AU (TGA)
Program insite® Powder-Free, Disposable Nitrile Exam Gloves

Program Insite, LLC

Cleared 2025-10-17

Registered with
  • US (FDA)
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)
ADVIA Centaur aHBs2 Assay

Siemens Healthcare Diagnostics

Cleared 2025-10-17

Registered with
  • US (FDA)
  • AU (TGA)
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC

Beckman Coulter, Inc.

Cleared 2025-10-17

Registered with
  • US (FDA)
  • AU (TGA)
Atellica IM Hepatitis B core IgM (aHBcM) Assay

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)
Atellica IM Hepatitis B e Antigen (HBeAg) Assay

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)
Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf)

SIEMENS AG

Cleared 2025-10-17

Registered with
  • US (FDA)
Blazer II XP Cardiac Ablation Catheter and Cable

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)
Blazer II Cardiac Ablation System and Cable

Boston Scientific Corp

Cleared 2025-10-17

Registered with
  • US (FDA)
Atellica® IM Anti-HBe2 Assay

Siemens Healthcare Diagnostics

Cleared 2025-10-17

Registered with
  • US (FDA)
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)