14 results · 23ms · Sources: EU EUDAMED, US FDA

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R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776412036·Cobb Curette, 11", Oval Cup, Angled, Size 6, Ho...

Oticon

FDA UDI
Sbo Hearing A/S·05714464053155·OTICON ZIRCON 2 MINIRITE R C093

COE TRAY PLASTIC™

FDA UDI
Gc America Inc.·D6582401931·COE TRAY PLASTIC™ Fast Set Liquid Can 1 Quart (...

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184027·Integra® Jarit® Cobb Style Bone Curette, 11", H...

COE TRAY PLASTIC™

FDA UDI
Gc America Inc.·10386040006460·COE TRAY PLASTIC™ Fast Set Liquid Can 1 Quart (...

DUREX EMBRACE PERSONAL LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MODEL GST-1

FDA 510(k)
FDA Class 2 ·Neurology

IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Adverse Event
Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 22, 2013

MCS GXL LINER 5/15 DEG 5052X28

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·April 20, 2023

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013