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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.

3,664 devices · when each source was last refreshed

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

Device
cobas HCV

Roche Molecular Systems, Inc.

Cleared 2025-11-03

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
3mensio Workstation

Pie Medical Imaging BV

Cleared 2025-11-03

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
ZAP-X Radiosurgery System (ZAP-X)

Zap Surgical Systems

Cleared 2025-11-03

Registered with
  • US (FDA)
NightGuard Aire Max

Nightguard Express, LLC

Cleared 2025-11-03

Registered with
  • US (FDA)
Kyphoplasty Balloon Dilatation Catheters

Shanghai Lange Medtech Co., Ltd.

Cleared 2025-11-03

Registered with
  • US (FDA)
cobas CMV

Roche Molecular Systems, Inc.

Cleared 2025-11-03

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Sonosite MT Ultrasound System

Fujifilm Sonosite Inc

Cleared 2025-11-03

Registered with
  • US (FDA)
  • Canada (Health Canada)
FRED

Microvention, Inc.

Cleared 2025-11-02

Registered with
  • US (FDA)
Chex-All Sterilization Pouches and Tubes

Propper Manufacturing Co., Inc.

Cleared 2025-10-31

Registered with
  • US (FDA)
Kii Structural Balloon Access System

Applied Medical Resources

Cleared 2025-10-31

Registered with
  • US (FDA)
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))

Persyst Development Corp.

Cleared 2025-10-31

Registered with
  • US (FDA)
Firebird SI Navigation System

ORTHOFIX US LLC

Cleared 2025-10-31

Registered with
  • US (FDA)
Freedom Metaphyseal Cone Implants (Metaphyseal Cones)

Maxx Orthopedics, Inc.

Cleared 2025-10-31

Registered with
  • US (FDA)
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);

Vigodent Indústria e Comércio Ltda

Cleared 2025-10-31

Registered with
  • US (FDA)
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)

Applied Medical Resources

Cleared 2025-10-31

Registered with
  • US (FDA)
Pulsenmore ES

Pulsenmore, Ltd.

Cleared 2025-10-31

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System

Becton Dickinson and Company

Cleared 2025-10-31

Registered with
  • US (FDA)
GREEN

Phasor Health, LLC

Cleared 2025-10-31

Registered with
  • US (FDA)
GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100

ACTUATED MEDICAL, INC.

Cleared 2025-10-31

Registered with
  • US (FDA)
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)

Shenzhen Sanping Image Technology Co., Ltd.

Cleared 2025-10-31

Registered with
  • US (FDA)
Diode Laser Hair Removal Machine (GLD01)

Sanhe Meditech Co.,Ltd

Cleared 2025-10-31

Registered with
  • US (FDA)
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

Canon Medical Systems Corporation

Cleared 2025-10-31

Registered with
  • US (FDA)
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)

Ceribell, Inc.

Cleared 2025-10-31

Registered with
  • US (FDA)
Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)

Boston Scientific Corp

Cleared 2025-10-30

Registered with
  • US (FDA)
Zoom System (Zoom 4S Catheter)

Imperative Care, Inc.

Cleared 2025-10-30

Registered with
  • US (FDA)
Arctx Cool Catheter Set

Arctx Medical

Cleared 2025-10-30

Registered with
  • US (FDA)
Niti-S Esophageal Stent; Esophageal TTS Stent

Taewoong Medical Co., Ltd.

Cleared 2025-10-30

Registered with
  • US (FDA)
ellacor System with Micro-Coring Technology

CYTRELLIS BIOSYSTEMS, INC.

Cleared 2025-10-30

Registered with
  • US (FDA)
Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Tornier, Inc

Cleared 2025-10-30

Registered with
  • US (FDA)
Freeprint® denture flex

Detax GmbH & Co. KG

Cleared 2025-10-30

Registered with
  • US (FDA)
AiORTA - Plan

ViTAA Medical Solutions, Inc.

Cleared 2025-10-30

Registered with
  • US (FDA)
  • Canada (Health Canada)
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)

DiaSorin Molecular LLC

Cleared 2025-10-30

Registered with
  • US (FDA)
HANAROSTENT Esophagus Upper (CCC)

M.I. TECH CO., LTD.

Cleared 2025-10-30

Registered with
  • US (FDA)
  • Canada (Health Canada)
BD Alaris Pump Infusion Set

Carefusion (Bd)

Cleared 2025-10-30

Registered with
  • US (FDA)
GEN5 and GEN5+ Dental Implant System

Paragon Implant Mfg., LLC

Cleared 2025-10-30

Registered with
  • US (FDA)
AIR COMPRESSION BOOTS 1018195,1018196

Merchsource, LLC

Cleared 2025-10-30

Registered with
  • US (FDA)
OBSIDIO™ Conformable Embolic (M0013972101010)

Boston Scientific Corp

Cleared 2025-10-30

Registered with
  • US (FDA)
AllTest Urinary Tract Infection Test

Hangzhou Alltest Biotech Co Ltd

Cleared 2025-10-30

Registered with
  • US (FDA)
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2025-10-30

Registered with
  • US (FDA)
Synchfix EVT

Wright Medical Technology, Inc. (Stryker)

Cleared 2025-10-29

Registered with
  • US (FDA)
Navilas Laser System 577sl (156691)

Od-Os GmbH

Cleared 2025-10-29

Registered with
  • US (FDA)
Freedom Infinia™ Total Knee System

Maxx Orthopedics, Inc.

Cleared 2025-10-29

Registered with
  • US (FDA)
LCD Monitor (C1216W, C822W, C821W)

Shenzhen Beacon Display Technology Co., Ltd.

Cleared 2025-10-29

Registered with
  • US (FDA)
Seguin Annuloplasty Ring

Abbott Medical

Cleared 2025-10-29

Registered with
  • US (FDA)
Difiney Advanced Anti Snoring Device 4.0

Fissiontech, LLC

Cleared 2025-10-29

Registered with
  • US (FDA)
LOGIQ E10s

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2025-10-29

Registered with
  • US (FDA)
Meduloc Intramedullary Fracture Fixation (IFF) System

Meduloc, LLC

Cleared 2025-10-29

Registered with
  • US (FDA)
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

Ortho-Clinical Diagnostics

Cleared 2025-10-29

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)

Shenzhen Root Innovation Technology Co., Ltd.

Cleared 2025-10-29

Registered with
  • US (FDA)
AETOS Shoulder System Meta Humeral Prosthesis Size 0

Smith & Nephew, Inc.

Cleared 2025-10-29

Registered with
  • US (FDA)