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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
HeartMate 3™ Left Ventricular Assist System (LVAS)

Abbott Medical

Cleared 2026-10-01

Registered with
  • US (FDA)
PROVIS OPHTHALMIC VISCOSURGICAL DEVICE

Alcon Research, Ltd.

Cleared 2026-10-01

Registered with
  • US (FDA)
NEXUS® Hip Stem

Microport Orthopedics, Inc.

Cleared 2026-10-01

Registered with
  • US (FDA)
SwiftSight-BodyComposition

Airs Medical, Inc.

Cleared 2026-10-01

Registered with
  • US (FDA)
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink

YTY INDUSTRY (MANJUNG) SDN BHD

Cleared 2026-10-01

Registered with
  • US (FDA)
CraniSeal Dural Sealant

Pramand, LLC

Cleared 2026-10-01

Registered with
  • US (FDA)
Intra-Operative Positioning System (IOPS) and IOPS Visionary System

Centerline Biomedical, Inc.

Cleared 2026-10-01

Registered with
  • US (FDA)
Harmony™ Transcatheter Pulmonary Valve System

Medtronic, Inc

Cleared 2026-09-30

Registered with
  • US (FDA)
  • AU (TGA)
danumed StomaMeter

Danumed Medizintechnik GmbH

Cleared 2026-09-30

Registered with
  • US (FDA)
  • UK (MHRA)
Duet™ Spinal Fixation System

Duet Spine Holdings, LLC

Cleared 2026-09-30

Registered with
  • US (FDA)
enVista Envy™ Hydrophobic Acrylic Intraocular Lens

Bausch & Lomb Incorporated

Cleared 2026-09-30

Registered with
  • US (FDA)
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System

Alcon Research, Ltd.

Cleared 2026-09-30

Registered with
  • US (FDA)
SAS MIS Pelvic Incidence Rods

Spinal Alignment Solutions, Inc.

Cleared 2026-09-30

Registered with
  • US (FDA)
Rapid Barostat Bag (RBB) Pump and Catheter System

Mui Scientific

Cleared 2026-09-30

Registered with
  • US (FDA)
Eonis™ SMA kit

Revvity, Inc.

Cleared 2026-09-30

Registered with
  • US (FDA)
EzSensor HD

Qpix Solutions, Inc.

Cleared 2026-09-30

Registered with
  • US (FDA)
Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)

Fussen Technology Co,Ltd

Cleared 2026-09-30

Registered with
  • US (FDA)
Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where "x" may be any numeric character).

Barco NV

Cleared 2026-09-30

Registered with
  • US (FDA)
ECG Analysis Software (AiTiALVSD)

Medical AI Co Ltd

Cleared 2026-09-30

Registered with
  • US (FDA)
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System

Alcon Research, Ltd.

Cleared 2026-09-30

Registered with
  • US (FDA)
enVista® Hydrophobic Acrylic Intraocular Lens (IOL); enVista® Hydrophobic Acrylic Intraocular Lens

Bausch & Lomb Incorporated

Cleared 2026-09-30

Registered with
  • US (FDA)
Elos Accurate Hybrid Base

Elos Medtech Pinol A/S

Cleared 2026-09-30

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Braun Aura 7 (6041)

Cyden Limited

Cleared 2026-09-30

Registered with
  • US (FDA)
CardioMEMS™ HF System

Abbott Medical

Cleared 2026-09-30

Registered with
  • US (FDA)
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine

Brainlab SE

Cleared 2026-09-30

Registered with
  • US (FDA)
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)

Centers For Disease Control and Prevention

Cleared 2026-09-30

Registered with
  • US (FDA)
THERMEO® I MSI

Pro3dure Medical GmbH

Cleared 2026-09-29

Registered with
  • US (FDA)
  • Canada (Health Canada)
CAS-One IR

Cascination AG

Cleared 2026-09-29

Registered with
  • US (FDA)
  • AU (TGA)
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web

C.R. Bard, Inc.

Cleared 2026-09-29

Registered with
  • US (FDA)
Spinalogic Bone Growth Stimulator

Djo, LLC

Cleared 2026-09-29

Registered with
  • US (FDA)
  • Canada (Health Canada)
Fast Absorbing PGLA

Riverpoint Medical

Cleared 2026-09-29

Registered with
  • US (FDA)
Elucid FFR-IQ (B.1)

Elucid Bioimaging, Inc.

Cleared 2026-09-29

Registered with
  • US (FDA)
Electric Wheelchair (0080)

Xuzhou Heabens Medical Technology Co., LTD.

Cleared 2026-09-29

Registered with
  • US (FDA)
NATRELLE SILICONE-FILLED BREST IMPLANTS

ALLERGAN

Cleared 2026-09-29

Registered with
  • US (FDA)
QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)

Qt Medical, Inc.

Cleared 2026-09-29

Registered with
  • US (FDA)
Syngo Carbon Space (VA4)

Siemens Healthineers AG

Cleared 2026-09-29

Registered with
  • US (FDA)
NeckTune™ SA Cervical Cage

Medyssey USA, Inc.

Cleared 2026-09-29

Registered with
  • US (FDA)
Power Mobility Scooter (MA03)

Nanjing MIJO Technology Co, Ltd

Cleared 2026-09-29

Registered with
  • US (FDA)
SmartRead(TM) Medical Device Identifier (4100)

BridgeSource Medical Corporation

Cleared 2026-09-29

Registered with
  • US (FDA)
LifeVest Wearable Defibrillator

Zoll Manufacturing Corporation

Cleared 2026-09-29

Registered with
  • US (FDA)
MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)

Zhejiang Kailang Technology Co., Ltd.

Cleared 2026-09-29

Registered with
  • US (FDA)
Simplera System; Simplera Sync

Medtronic Minimed

Cleared 2026-09-29

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Phasix ST Parastomal Hernia Mesh

Davol, Inc., A Subsidiary of C.R. Bard, Inc.

Cleared 2026-09-28

Registered with
  • US (FDA)
Alians Forearm

Newclip Technics S.A.S

Cleared 2026-09-28

Registered with
  • US (FDA)
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)

bioMérieux SA

Cleared 2026-09-28

Registered with
  • US (FDA)
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Cochlear Americas

Cleared 2026-09-28

Registered with
  • US (FDA)
Tri Stage Venous Cannulae

Sorin Group Italia S.R.L.

Cleared 2026-09-28

Registered with
  • US (FDA)
Nucleus Hybrid L24 Implant System

Cochlear Americas

Cleared 2026-09-28

Registered with
  • US (FDA)
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI

Cochlear Americas

Cleared 2026-09-28

Registered with
  • US (FDA)
Liora Monofilament Scaffold

Tela Bio, Inc.

Cleared 2026-09-28

Registered with
  • US (FDA)