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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.

3,665 devices · when each source was last refreshed

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

Device
AcrySoft Intraocular Lenses

Alcon Laboratories

Cleared 2026-07-08

Registered with
  • US (FDA)
ThermAffyx(TM) Patient Safety System

Stihler Electronic GmbH

Cleared 2026-07-08

Registered with
  • US (FDA)
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

bioMérieux SA

Cleared 2026-07-08

Registered with
  • US (FDA)
C.A. Medical Interbody Fusion System

C.A. Medical, LLC

Cleared 2026-07-08

Registered with
  • US (FDA)
CXRDetectAI

Neurocareai, Inc. (Dba Savelife.Ai)

Cleared 2026-07-08

Registered with
  • US (FDA)
Luja Soft

Coloplast Corp.

Cleared 2026-07-07

Registered with
  • US (FDA)
comfilcon A Soft (Hydrophilic) Contact Lenses for Extended Wear

CooperVision, Inc.

Cleared 2026-07-07

Registered with
  • US (FDA)
Mobility Scooter (R200)

Yongkang Ruihe Metal Product Co., Ltd.

Cleared 2026-07-07

Registered with
  • US (FDA)
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens

HOYA LAMPHUN LTD.

Cleared 2026-07-07

Registered with
  • US (FDA)
Electric wheelchair (XW-LY007 )

Yongkang Ruihe Metal Product Co., Ltd.

Cleared 2026-07-07

Registered with
  • US (FDA)
InferOperate Suite

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Cleared 2026-07-07

Registered with
  • US (FDA)
Pulmonex II Xenon System (132-503)

Mirion Technologies (Capintec), Inc

Cleared 2026-07-07

Registered with
  • US (FDA)
Roadsaver/CASPER Carotid Stent System

Microvention, Inc.

Cleared 2026-07-07

Registered with
  • US (FDA)
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

Sterilance Medical(Suzhou), Inc.

Cleared 2026-07-06

Registered with
  • US (FDA)
CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42

Numed, Inc.

Cleared 2026-07-06

Registered with
  • US (FDA)
  • AU (TGA)
Synergy Disc

Synergy Spine Solutions Inc

Cleared 2026-07-06

Registered with
  • US (FDA)
  • UK (MHRA)
AcrySof ReSTOR® Apodized Diffractive Optic Posterior Chamber IOL

Alcon Research, Ltd.

Cleared 2026-07-06

Registered with
  • US (FDA)
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)

Hartman Medical Group, LLC

Cleared 2026-07-06

Registered with
  • US (FDA)
Guardant360® Liquid CDx

Guardant Health, Inc.

Cleared 2026-07-06

Registered with
  • US (FDA)
TESSA Spatial Surgery System; INTELLIO Tablet (72205455)

Smith & Nephew, Inc.

Cleared 2026-07-06

Registered with
  • US (FDA)
INDIRA CLOUD VIEWER

INDIGO TECHNOLOGIES

Cleared 2026-07-06

Registered with
  • US (FDA)
MobileLink Acetabular Cup System – 40mm ID Inserts (various)

Waldemar Link GmbH & Co. KG

Cleared 2026-07-06

Registered with
  • US (FDA)
Cytrans™ Elashield

GC AMERICA INC.

Cleared 2026-07-06

Registered with
  • US (FDA)
Plum Vagiceuticals™ Vaginal Moisturizing Suppositories

PCCA Limited

Cleared 2026-07-06

Registered with
  • US (FDA)
Fastplex™ BCR-ABL (p210) %IS digital PCR Kit

Suzhou Precigenome Ltd, Co;

Cleared 2026-07-02

Registered with
  • US (FDA)
OrthoFit

Spident Co., Ltd.

Cleared 2026-07-02

Registered with
  • US (FDA)
OncoStudio

Oncosoft. Co., Ltd.

Cleared 2026-07-02

Registered with
  • US (FDA)
ILR ECG Analyzer (IM007)

Implicity

Cleared 2026-07-02

Registered with
  • US (FDA)
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter

Abbott GmbH

Cleared 2026-07-02

Registered with
  • US (FDA)
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology

O&M Halyard, Inc.

Cleared 2026-07-02

Registered with
  • US (FDA)
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)

Edan Instruments, Inc

Cleared 2026-07-02

Registered with
  • US (FDA)
MI Cancer Seek

Caris Life Sciences

Cleared 2026-07-02

Registered with
  • US (FDA)
Xpert Carba-R

Cepheid®

Cleared 2026-07-02

Registered with
  • US (FDA)
OptraSCAN System

OptraSCAN Inc.

Cleared 2026-07-02

Registered with
  • US (FDA)
Insufflation Retention Device (IRD) (11173-325-101)

Bpendo, LLC

Cleared 2026-07-02

Registered with
  • US (FDA)
iTero Lumina Pro

Align Technology Ltd

Cleared 2026-07-02

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
FACE4D Aligner

AVINENT IMPLANT SYSTEM, SLU

Cleared 2026-07-02

Registered with
  • US (FDA)
FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01

FUJIFILM Corporation

Cleared 2026-07-02

Registered with
  • US (FDA)
Collagen Wound Powder

Ventris Medical

Cleared 2026-07-02

Registered with
  • US (FDA)
Koios DS (3.8)

Koios Medical, Inc.

Cleared 2026-07-02

Registered with
  • US (FDA)
Claria System

Claria Medical, Inc.

Cleared 2026-07-02

Registered with
  • US (FDA)
iPredict-DR

iHealthScreen Inc

Cleared 2026-07-02

Registered with
  • US (FDA)
DENTCA Tru Flexible

Dentca, Inc.

Cleared 2026-07-01

Registered with
  • US (FDA)
  • Canada (Health Canada)
Optune Pax

Novocure, GmbH

Cleared 2026-07-01

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)

Olympus Medical Systems Corporation

Cleared 2026-07-01

Registered with
  • US (FDA)
Optune Lua

Novocure, GmbH

Cleared 2026-07-01

Registered with
  • US (FDA)
  • EU (EUDAMED)
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

Siemens Medical Solutions USA, Inc.

Cleared 2026-07-01

Registered with
  • US (FDA)
Veritas Shoulder System

Restor3d

Cleared 2026-07-01

Registered with
  • US (FDA)
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)

Covidien

Cleared 2026-07-01

Registered with
  • US (FDA)
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE)

W. L. Gore and Associates, Inc.

Cleared 2026-07-01

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