HaRi
Start Free→

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.

3,686 devices · when each source was last refreshed

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

Device
CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC & ATLAS ICD FAMILIES

Abbott Medical

Cleared 2026-08-12

Registered with
  • US (FDA)
APRO 35 Swift Catheter

Alembic, LLC

Cleared 2026-08-12

Registered with
  • US (FDA)
ManaCold Compression System

Manamed, Inc.

Cleared 2026-08-12

Registered with
  • US (FDA)
EluPro Antibiotic-Eluting BioEnvelope

Boston Scientific Corp

Cleared 2026-08-12

Registered with
  • US (FDA)
MASIMO ROOT MONITORING SYSTEM

Masimo Corp.

Cleared 2026-08-12

Registered with
  • US (FDA)
FoundationOne CDx (F1CDx)

Foundation Medicine, Inc.

Cleared 2026-08-12

Registered with
  • US (FDA)
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)

Hologic Inc

Cleared 2026-08-12

Registered with
  • US (FDA)
Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)

Hangzhou Ruidi Biotechnology Ltd.

Cleared 2026-08-12

Registered with
  • US (FDA)
Large Compression Screws

Trimed Pvt Ltd

Cleared 2026-08-12

Registered with
  • US (FDA)
Millipede System

Perfuze, Ltd.

Cleared 2026-08-12

Registered with
  • US (FDA)
NeuroQuant PET

Cortechs Labs, Inc.

Cleared 2026-08-12

Registered with
  • US (FDA)
SenTiva™ Generator, SenTiva Duo™ Generator

LivaNova USA Inc

Cleared 2026-08-12

Registered with
  • US (FDA)
Avant (CDHFA700Q, CDHFA700T, CDHFA700D); Neutrino NxT (CDHFA800Q, CDHFA800T, CDHFA800B, CDHFA800D, CDHFA600Q, CDHFA600T,

Abbott Medical

Cleared 2026-08-12

Registered with
  • US (FDA)
Vashe Plus Antimicrobial Solution

URGO MEDICAL NORTH AMERICA, LLC

Cleared 2026-08-11

Registered with
  • US (FDA)
Stelo Glucose Biosensor System

Dexcom, Inc.

Cleared 2026-08-11

Registered with
  • US (FDA)
VR® Personal Protective Level 4 Gown (VR Gowns)

PolyConversions, Inc.

Cleared 2026-08-11

Registered with
  • US (FDA)
Dexter L6 System

Distalmotion SA

Cleared 2026-08-11

Registered with
  • US (FDA)
Q Switched Nd:YAG Laser machine (QLQW-01)

Beijing Nubway S&T Co., Ltd.

Cleared 2026-08-11

Registered with
  • US (FDA)
INNOVANCE® D-Dimer 2.0 (SMN 10873803)

Siemens Healthcare Diagnostic Products GmbH

Cleared 2026-08-11

Registered with
  • US (FDA)
Current™ PFA Generator – TactiFlex Duo

Abbott Medical

Cleared 2026-08-11

Registered with
  • US (FDA)
  • Canada (Health Canada)
Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves

Abbott Medical

Cleared 2026-08-11

Registered with
  • US (FDA)
Hair Removal Device (R3C16-G Pro, R3C16-V Pro)

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Cleared 2026-08-10

Registered with
  • US (FDA)
Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)

Nova Eye Inc

Cleared 2026-08-10

Registered with
  • US (FDA)
Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX Transcatheter Aortic Valve Repl

Medtronic, Inc

Cleared 2026-08-10

Registered with
  • US (FDA)
Mobility Scooter (W3483, W3483A)

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

Cleared 2026-08-10

Registered with
  • US (FDA)
Atellica IM CA 19-9 II

Siemens Healthcare Diagnostics

Cleared 2026-08-10

Registered with
  • US (FDA)
Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai

Boston Scientific Corp

Cleared 2026-08-10

Registered with
  • US (FDA)
Icona Hip Stem

Corin Limited

Cleared 2026-08-10

Registered with
  • US (FDA)
Mobility Scooter (W3465, W3902 (S50 Carbon))

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

Cleared 2026-08-10

Registered with
  • US (FDA)
EM-TECH Passive Ultrasound Probe Strap

EM-TECH Solutions, Inc.

Cleared 2026-08-10

Registered with
  • US (FDA)
Hemoclip (511 series, 543 series)

Hangzhou AGS MedTech Co., Ltd.

Cleared 2026-08-10

Registered with
  • US (FDA)
Claire™ OCT System

Perimeter Medical Imaging Ai, Inc.

Cleared 2026-08-10

Registered with
  • US (FDA)
Eye Recovery Pro (PH-e03)

Shenzhen Goodwind Technology Development Co., Ltd.

Cleared 2026-08-10

Registered with
  • US (FDA)
Novii+ Wireless Patch System

Datex-Ohmeda, Inc

Cleared 2026-08-10

Registered with
  • US (FDA)
  • Canada (Health Canada)
Spinal Cord Stimulation (SCS)

Boston Scientific Corp

Cleared 2026-08-10

Registered with
  • US (FDA)
Prostate Core

Lucida Medical Ltd

Cleared 2026-08-10

Registered with
  • US (FDA)
Unimpregnated Central Venous Catheter

SPECTRUM VASCULAR

Cleared 2026-08-10

Registered with
  • US (FDA)
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)

Hh Global Technology, Inc.

Cleared 2026-08-10

Registered with
  • US (FDA)
Metrix COVID Test; Metrix COVID Test Pro

Aptitude Medical Systems, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
Tendyne™ Transcatheter Mitral Valve

Abbott Medical

Cleared 2026-08-07

Registered with
  • US (FDA)
Xpert Hemorrhagic Fever

Cepheid Inc

Cleared 2026-08-07

Registered with
  • US (FDA)
Aperio iQC DX Software

Leica Biosystems Imaging, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Zamenix™ P

Roen Surgical, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
EW10-EC02 Endoscopy Support Program

FUJIFILM Corporation

Cleared 2026-08-07

Registered with
  • US (FDA)
Deep Brain Stimulation (DBS) IPG

Abbott Medical

Cleared 2026-08-07

Registered with
  • US (FDA)
THERAPY COOL PATH ABLATION CATHETER

Irvine Biomedical, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
PacTemp Automix NE

THE BELPORT COMPANY, INC. DBA GINGI-PAK

Cleared 2026-08-07

Registered with
  • US (FDA)
LIVEWIRE TC CARDIAC ABLATION CATHETER

St. Jude Medical, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)

HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.

Cleared 2026-08-07

Registered with
  • US (FDA)
Zenition 30

Philips Medical Systems Nederland BV

Cleared 2026-08-07

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