11 results
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20ms
·
Sources: EU EUDAMED, US FDA
ACCU-LINE SURGICAL MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Midwest Power Lux Implant Motor
FDA UDI
SIRONA Dental Systems GmbH·E27668302980·Midwest Power Lux Implant Motor
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Celsi Monitor
FDA 510(k)
FDA Class 2
·General Hospital
NAIL HOLDING SCREW
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·January 6, 2012
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·July 10, 2018
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 10, 2018
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE·Product code KDJ·May 23, 2014
COYOTE¿ ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·November 13, 2012
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2015
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025