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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.

3,659 devices · when each source was last refreshed

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

Device
XVIVO Perfusion System (XPS)™ with STEEN Solution™ Perfusate

Xvivo Perfusion AB

Cleared 2026-09-16

Registered with
  • US (FDA)
X°Port Heart Preservation System

TRAFEROX TECHNOLOGIES INC.

Cleared 2026-09-16

Registered with
  • US (FDA)
NC PTA Balloon Dilatation Catheter

Kossel Medtech (Suzhou) Co., Ltd.

Cleared 2026-09-16

Registered with
  • US (FDA)
Dia-X Sil Light Body

DiaDent Group International

Cleared 2026-09-16

Registered with
  • US (FDA)
Dia-X Sil Heavy Body

DiaDent Group International

Cleared 2026-09-16

Registered with
  • US (FDA)
LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level)

Highridge Medical LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
i-FACTOR® Peptide Enhanced Graft Substitute

Cerapedics, LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large

Ambu AS

Cleared 2026-09-16

Registered with
  • US (FDA)
Embrace Vision Neonatal MRI System

Aspect Imaging, Ltd.

Cleared 2026-09-16

Registered with
  • US (FDA)
a2z-Abdo-Triage

A2z Radiology Ai, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
AerFrame™ Alignment Laser Box (LBV2)

Stabilix, LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
Mouth Guard

ChangSha ChuangDuoLe E-Commerce Co., Ltd.

Cleared 2026-09-16

Registered with
  • US (FDA)
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)

GT METABOLIC SOLUTIONS, INC.

Cleared 2026-09-16

Registered with
  • US (FDA)
Shield

Guardant Health, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

Amptron Medical, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
TMC Implant Fixation System

Treace Medical Concepts, Inc.

Cleared 2026-09-15

Registered with
  • US (FDA)
NAVISTAR RMT THERMOCOOL

Biosense Webster, Inc.

Cleared 2026-09-15

Registered with
  • US (FDA)
  • UK (MHRA)
LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated

Covidien

Cleared 2026-09-15

Registered with
  • US (FDA)
VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU)

Biosense Webster, Inc.

Cleared 2026-09-15

Registered with
  • US (FDA)
Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)

Zhenjiang Assure Medical Equipment Co., Ltd.

Cleared 2026-09-15

Registered with
  • US (FDA)
OncoMate® MSI Dx Analysis System

Promega Corporation

Cleared 2026-09-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Cerene Cryotherapy Device

Channel Medsystems, Inc.

Cleared 2026-09-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
QDOT MICRO Uni-Directional Navigation Catheter

Biosense Webster, Inc.

Cleared 2026-09-15

Registered with
  • US (FDA)
OOOPDS

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Cleared 2026-09-15

Registered with
  • US (FDA)
CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)

Karl Storz SE & CO.KG

Cleared 2026-09-15

Registered with
  • US (FDA)
YJ-K1K2 Wheelchair (YJ-013F)

Zhenjiang Assure Medical Equipment Co., Ltd.

Cleared 2026-09-15

Registered with
  • US (FDA)
Artificial Intelligence Renal Assessment (AIRA) Version 1

Aramis Global AI Consultancies, LLC

Cleared 2026-09-15

Registered with
  • US (FDA)
SPINEsim v1.0

Mdsim S.A.

Cleared 2026-09-15

Registered with
  • US (FDA)
CVAC Aspiration System

Calyxo, Inc.

Cleared 2026-09-15

Registered with
  • US (FDA)
Dual Energy THERMOCOOL SMARTTOUCH SF™ System

Biosense Webster, Inc.

Cleared 2026-09-15

Registered with
  • US (FDA)
Tontarra Punches and Rongeurs

TONTARRA Medizintechnik GmbH

Cleared 2026-09-15

Registered with
  • US (FDA)
Reclining wheelchair (YJ-013L)

Zhenjiang Assure Medical Equipment Co., Ltd.

Cleared 2026-09-15

Registered with
  • US (FDA)
GMK EXTENSION

Medacta International S.A.

Cleared 2026-09-15

Registered with
  • US (FDA)
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses

Bausch & Lomb Incorporated

Cleared 2026-09-14

Registered with
  • US (FDA)
RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology

Xenix Medical

Cleared 2026-09-14

Registered with
  • US (FDA)
Altaviva™

Medtronic Neuromodulation

Cleared 2026-09-14

Registered with
  • US (FDA)
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)

Eurosets Srl

Cleared 2026-09-14

Registered with
  • US (FDA)
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Boston Scientific Corp

Cleared 2026-09-14

Registered with
  • US (FDA)
Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit

Maduro Medical, Inc.

Cleared 2026-09-14

Registered with
  • US (FDA)
colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

Ovesco Endoscopy AG

Cleared 2026-09-14

Registered with
  • US (FDA)
InterStim® Therapy System

Medtronic Neuromodulation

Cleared 2026-09-14

Registered with
  • US (FDA)
qCT Lung (v1.0)

Qure.Ai Technologies

Cleared 2026-09-14

Registered with
  • US (FDA)
Hand-held Dental X-ray System (HyperLight-M)

Changzhou Sifary Medical Technology Co, Ltd,

Cleared 2026-09-14

Registered with
  • US (FDA)
BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth

Becton Dickinson and Company

Cleared 2026-09-14

Registered with
  • US (FDA)
Yumizen H550

HORIBA ABX SAS

Cleared 2026-09-14

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
AMS 800 URINARY CONTROL SYSTEM

Boston Scientific Corp

Cleared 2026-09-14

Registered with
  • US (FDA)
  • AU (TGA)
Safety lancet (XL)

Tianjin Huahong Technology Co, Ltd

Cleared 2026-09-13

Registered with
  • US (FDA)
Digistat Care

Ascom Ums Srl Unipersonale

Cleared 2026-09-12

Registered with
  • US (FDA)
CADDIE

Odin Medical Limited

Cleared 2026-09-12

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
GSPE Spacer

The General Hospital Corporation, d/b/a Massachusetts

Cleared 2026-09-11

Registered with
  • US (FDA)