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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
Atellica IM CA 19-9 II

Siemens Healthcare Diagnostics

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)
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)
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)
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)
THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER

Abbott Medical

Cleared 2026-08-07

Registered with
  • US (FDA)
mdprostate

mediaire GmbH

Cleared 2026-08-07

Registered with
  • US (FDA)
  • UK (MHRA)
Mistral-Air® Warming System

THE SURGICAL COMPANY INTERNATIONAL B.V. DOING BUSINESS AS TSC LIFE

Cleared 2026-08-07

Registered with
  • US (FDA)
Arthrex Bioabsorbable PushLock Suture Anchors

Arthrex, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
Aperio GT 450 DX; Aperio GT 180 DX

Leica Biosystems Imaging, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)

Shenzhen Chuangtong Yigou Technology Co., Ltd.

Cleared 2026-08-07

Registered with
  • US (FDA)
Intuitive Endoluminal Gastrointestinal System (IG1000)

Intuitive Surgical, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
Bellafill Dermal Filler

TIGER AESTHETICS MEDICAL, LLC

Cleared 2026-08-07

Registered with
  • US (FDA)
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

YADU Medical (Henan) Co, Ltd

Cleared 2026-08-07

Registered with
  • US (FDA)
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

St. Jude Medical, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
Venue Go

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-08-07

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

Bumlicious, LLC (DBA "Bumlicious")

Cleared 2026-08-07

Registered with
  • US (FDA)
PerClot® Polysaccharide Hemostatic System

Baxter Healthcare Corp

Cleared 2026-08-07

Registered with
  • US (FDA)
Axonics Sacral Neuromodulation (SNM) System

Boston Scientific Corp

Cleared 2026-08-07

Registered with
  • US (FDA)
Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

Lakong Medical Devices Co., Ltd.

Cleared 2026-08-07

Registered with
  • US (FDA)
Freedom Total Knee System (E-Poly Tibial Liners)

Maxx Orthopedics, Inc.

Cleared 2026-08-07

Registered with
  • US (FDA)
OrganOx metra System

Organox Limited

Cleared 2026-08-07

Registered with
  • US (FDA)
QIAstat-Dx BCID GPF Plus AMR Panel

QIAGEN GmbH

Cleared 2026-08-06

Registered with
  • US (FDA)
  • EU (EUDAMED)
Aristotle Mini Guidewire

Scientia Vascular, LLC

Cleared 2026-08-06

Registered with
  • US (FDA)
Manual Wheelchair (H008, PCK7)

Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.

Cleared 2026-08-06

Registered with
  • US (FDA)
Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw

Nobel Biocare AB

Cleared 2026-08-06

Registered with
  • US (FDA)
Telemetry Monitor (iT30, iT50)

Edan Instruments, Inc

Cleared 2026-08-06

Registered with
  • US (FDA)
Overjet Multi-Image Caries and Charting Assist

Overjet, Inc.

Cleared 2026-08-06

Registered with
  • US (FDA)
EluNIR™ Ridaforolimus Eluting Coronary Stent System

Medinol , Ltd.

Cleared 2026-08-06

Registered with
  • US (FDA)
Megalodon Dynamic Compression System

Paragon 28, Inc

Cleared 2026-08-06

Registered with
  • US (FDA)
Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)

Mozarc Medical US LLc

Cleared 2026-08-06

Registered with
  • US (FDA)
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Cleared 2026-08-06

Registered with
  • US (FDA)
NaturaJel™ Oral Wound Care Kit

HCS Innovation, LLC

Cleared 2026-08-05

Registered with
  • US (FDA)
GFS - Sterile Screws and Top Hat

Tag Medical Products

Cleared 2026-08-05

Registered with
  • US (FDA)