11 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Cyclops Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA Centaur® Sample Tips
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414222608·Pipette tip
TRACTUS TISSUEMAPPER REVIEWER APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 28, 2025
DAFILON BLUE 5/0 (1) 45CM DSMP13 (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAR·October 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023