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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.

3,670 devices · when each source was last refreshed

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

Device
VALITUDE™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U

Guidant Corp.

Cleared 2026-10-03

Registered with
  • US (FDA)
ESSENTIO™ MRI SR SL (L110); ESSENTIO™ MRI DR SL (L111); ESSENTIO™ MRI DR EL (L131); PROPONENT™ MRI SR SL (L210); PROPONE

Boston Scientific Corp

Cleared 2026-10-03

Registered with
  • US (FDA)
ESSENTIO™ SR SL (L100); ESSENTIO™ DR SL (L101); ESSENTIO™ DR EL (L121); PROPONENT™ SR SL (L200); PROPONENT™ DR SL (L201)

Boston Scientific Corp

Cleared 2026-10-03

Registered with
  • US (FDA)
Response Ortho Smart Fixator - Hexapod System

Response Ortho Solutions, LLC

Cleared 2026-10-02

Registered with
  • US (FDA)
REMEX-T(K)100C

Remedi Co., Ltd.

Cleared 2026-10-02

Registered with
  • US (FDA)
Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)

Barco NV

Cleared 2026-10-02

Registered with
  • US (FDA)
stentFIX System Set (100.50n)

Ovesco Endoscopy AG

Cleared 2026-10-02

Registered with
  • US (FDA)
cCeLL405

VPIX Medical, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
Lung Guidance

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-10-02

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
FARAPULSE™ Pulsed Field Ablation System

Farapulse, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219)

Boston Scientific Corp

Cleared 2026-10-02

Registered with
  • US (FDA)
AltiVate Reverse® Glenosphere with RAVN™ Technology

Encore Medical LP

Cleared 2026-10-02

Registered with
  • US (FDA)
Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System

SPINAL SIMPLICITY LLC

Cleared 2026-10-02

Registered with
  • US (FDA)
Ventricular Catheters, Thomale Catheter

Aesculap, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)

Shenzhen Ninenovo Technology Limited

Cleared 2026-10-02

Registered with
  • US (FDA)
MediBeacon® Transdermal GFR Measurement System (GFR)

Medibeacon, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
OAB Delivery Catheter

Cognition Medical Corp.

Cleared 2026-10-02

Registered with
  • US (FDA)
HexaGen RF Generator Software and Remote

Medtronic, Inc

Cleared 2026-10-02

Registered with
  • US (FDA)
  • UK (MHRA)
Hemostatic Clip

Anrei Medical (HZ) Co, Ltd

Cleared 2026-10-02

Registered with
  • US (FDA)
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-10-02

Registered with
  • US (FDA)
MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor

STERIS SAS

Cleared 2026-10-02

Registered with
  • US (FDA)
AnyPlus II Spinal Fixation System

GS Medical Co., Ltd.

Cleared 2026-10-02

Registered with
  • US (FDA)
OneStep CPR Complete Electrodes, OneStep CPR Complete Adult/Child Electrodes, OneStep CPR AA Electrodes, OneStep CPR Ele

Zoll Medical Corp

Cleared 2026-10-02

Registered with
  • US (FDA)
  • UK (MHRA)
CVS Advanced PLUS Blood Glucose Monitoring System

I-Sens, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
ZSAlign Cervical Interbody System

Zsfab, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
Elecsys EBV VCA IgG

Roche Diagnostics GmbH

Cleared 2026-10-02

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
H100Plus Hemoglobin Testing System

Shenzhen Lifotronic Technology Co, Ltd

Cleared 2026-10-02

Registered with
  • US (FDA)
Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants

Motiva, USA, LLC

Cleared 2026-10-02

Registered with
  • US (FDA)
Elecsys EBV EBNA IgG

Roche Diagnostics GmbH

Cleared 2026-10-02

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
SenTiva™ Generator, SenTiva Duo™ Generator

LivaNova USA Inc

Cleared 2026-10-02

Registered with
  • US (FDA)
Elecsys EBV IgM

Roche Diagnostics GmbH

Cleared 2026-10-02

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Plenity-V (MC0979 / GS110)

Gelesis, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
CentriMag Circulatory Support System

Abbott GmbH

Cleared 2026-10-02

Registered with
  • US (FDA)
Medical Monitor (32MD08WC)

Lg Electronics

Cleared 2026-10-02

Registered with
  • US (FDA)
TDM Large Bone Plate and Screw System

Tdm Co., Ltd.

Cleared 2026-10-02

Registered with
  • US (FDA)
OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts

Osteocentric Technologies

Cleared 2026-10-02

Registered with
  • US (FDA)
Neurora

Argus Cognitive, Inc.

Cleared 2026-10-02

Registered with
  • US (FDA)
Xpert Xpress CoV-2/Flu plus

Cepheid®

Cleared 2026-10-02

Registered with
  • US (FDA)
Autus Size-Adjustable Valve

Edwards Lifesciences, LLC

Cleared 2026-10-01

Registered with
  • US (FDA)
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)

bioMérieux SA

Cleared 2026-10-01

Registered with
  • US (FDA)
HeartMate II Left Ventricular Assist System (LVAS)

Abbott Medical

Cleared 2026-10-01

Registered with
  • US (FDA)
Firstar Dental Handpieces

FDC TECHNOLOGY INDUSTRY CO.

Cleared 2026-10-01

Registered with
  • US (FDA)
Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)

Shenzhen Brav Electronic Technologies Co., Ltd.

Cleared 2026-10-01

Registered with
  • US (FDA)
Firstar Dental Electric Motor

FDC TECHNOLOGY INDUSTRY CO.

Cleared 2026-10-01

Registered with
  • US (FDA)
iStent inject® W Trabecular Micro-Bypass System

Glaukos

Cleared 2026-10-01

Registered with
  • US (FDA)
  • AU (TGA)
NOVIX Pedicle Screw System

Tdm Co., Ltd.

Cleared 2026-10-01

Registered with
  • US (FDA)
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System

Alcon Laboratories

Cleared 2026-10-01

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent Systems

Abbott Vascular, Inc.

Cleared 2026-10-01

Registered with
  • US (FDA)
EXCOR Pediatric Ventricular Assist Device

Berlin Heart, Inc.

Cleared 2026-10-01

Registered with
  • US (FDA)
Dual Stage Venous Cannulae

Sorin Group Italia S.R.L.

Cleared 2026-10-01

Registered with
  • US (FDA)