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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
SCENARIA View Phase 6.0

FUJIFILM Corporation

Cleared 2026-09-18

Registered with
  • US (FDA)
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)

Shenzhen Mericonn Technology Co., Ltd

Cleared 2026-09-18

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

Abbott Medical

Cleared 2026-09-18

Registered with
  • US (FDA)
Guardant360 CDx

Guardant Health, Inc.

Cleared 2026-09-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Triever Duo Catheter

Inari Medical, Inc.

Cleared 2026-09-18

Registered with
  • US (FDA)
Optune Gio

Novocure, GmbH

Cleared 2026-09-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Deterioration Index Version 2

Epic Systems, Inc.

Cleared 2026-09-18

Registered with
  • US (FDA)
MINT MONO Sutures

Hans Biomed Corp.

Cleared 2026-09-18

Registered with
  • US (FDA)
SCULPTRA® (injectable poly-L Lactic acid)

Q-Med AB

Cleared 2026-09-17

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
LED Therapy Device (QLXY-01)

Beijing Nubway S&T Co., Ltd.

Cleared 2026-09-17

Registered with
  • US (FDA)
Unity Total Knee System, Unity Knee Cementless CR Femur

Corin Limited

Cleared 2026-09-17

Registered with
  • US (FDA)
Hygienic Protective Bite Cover (2207-010-50)

DURR DENTAL SE

Cleared 2026-09-17

Registered with
  • US (FDA)
Synergy Disc

Synergy Spine Solutions Inc

Cleared 2026-09-17

Registered with
  • US (FDA)
  • UK (MHRA)
MOWANA AUTO DUO

Pentamaster MediQ Sdn. Bhd.

Cleared 2026-09-17

Registered with
  • US (FDA)
  • EU (EUDAMED)
Vessel Closure Device (VCD177213P)

Vcd Medical S.R.L.

Cleared 2026-09-17

Registered with
  • US (FDA)
FRAXION Spinal Fixation System

Ortler Global Tibbi Gerecler Anonim Sirketi

Cleared 2026-09-17

Registered with
  • US (FDA)
ZENITH FLEX AAA ENDOVASCULAR GRAFT

Cook, Inc.

Cleared 2026-09-17

Registered with
  • US (FDA)
  • UK (MHRA)
ENDOTAK,ENDOTAK ENDURANCE, ENDOTAK RELIANCE

Boston Scientific Corp

Cleared 2026-09-17

Registered with
  • US (FDA)
Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

Zhengzhou PZ Laser Slim Technology Co Limited

Cleared 2026-09-17

Registered with
  • US (FDA)
The VEGA Cervical Screw System

GS Medical Co., Ltd.

Cleared 2026-09-17

Registered with
  • US (FDA)
TriActive Dental Implant System

PARAGON IMPLANT MFG., LLC

Cleared 2026-09-17

Registered with
  • US (FDA)
M-Vizion Femoral Revision System Extension

Medacta International S.A.

Cleared 2026-09-17

Registered with
  • US (FDA)
Durashield Device Kit

SurGenTec, LLC

Cleared 2026-09-17

Registered with
  • US (FDA)
Wearable Breast Pump (Model S36)

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2026-09-17

Registered with
  • US (FDA)
HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)

Ethicon Endo-Surgery, Inc.

Cleared 2026-09-17

Registered with
  • US (FDA)
Protégé™ EverFlex™ Self-expanding Peripheral Stent System

Medtronic, Inc

Cleared 2026-09-17

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
EnSite X EP System

Abbott Medical

Cleared 2026-09-17

Registered with
  • US (FDA)
Integrity Retractable Implant Inserter (6000127)

Anika Therapeutics, Inc

Cleared 2026-09-17

Registered with
  • US (FDA)
Miru 1day UpSide (midafilcon A)

Menicon Co, Ltd

Cleared 2026-09-17

Registered with
  • US (FDA)
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)

Stryker Instruments

Cleared 2026-09-17

Registered with
  • US (FDA)
Exablate Model 4000 Type 1.0 and 1.1 ("Exablate Neuro"; "Exablate Prime")

Insightec, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
iOS CamAPS FX

Camdiab , Ltd.

Cleared 2026-09-16

Registered with
  • US (FDA)
PearlMatrix™ Peptide Enhanced Bone Graft

Cerapedics, LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
Route 92 Medical Full Length 046 Access System

Route 92 Medical, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
EVOQUE Tricuspid Delivery System (9850TDS); EVOQUE dilator kit (9850DK)

Edwards Lifesciences, LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
  • AU (TGA)
Ceribell EEG Analysis Software

Ceribell, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

Ambu AS

Cleared 2026-09-16

Registered with
  • US (FDA)
MOBI-C CERVICAL DISC PROSTHESIS

Highridge Medical LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
LVIS

Microvention, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))

GUANGDONG NEWDERMO BIOTECH CO., LTD

Cleared 2026-09-16

Registered with
  • US (FDA)
Multifunctional wheelchair (YJ-059)

Zhenjiang Assure Medical Equipment Co., Ltd.

Cleared 2026-09-16

Registered with
  • US (FDA)
JADE SCORE PTA Scoring Balloon Dilatation Catheter

OrbusNeich Medical (Shenzhen) Co., Ltd.

Cleared 2026-09-16

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

Foundation Medicine, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
Aristotle 65 Macrowire

Scientia Vascular, LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)

Olympus Surgical Technologies America

Cleared 2026-09-16

Registered with
  • US (FDA)
MicroTransponder Vivistim Paired VNS System (Vivistim System)

Mobia Medical, Inc.

Cleared 2026-09-16

Registered with
  • US (FDA)
EchoPAC Software Only / EchoPAC Plug-in (v211)

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-09-16

Registered with
  • US (FDA)
ClearClub Impression Material

ClearClub

Cleared 2026-09-16

Registered with
  • US (FDA)
Electric Wheelchair

Yongkang Joymax Medical Technology Co, Ltd

Cleared 2026-09-16

Registered with
  • US (FDA)
  • AU (TGA)
APERTO Lucent MRI System

FUJIFILM Corporation

Cleared 2026-09-16

Registered with
  • US (FDA)