14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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