18 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OSTEOGRAF/LD-300 HYDROXYLAPATITE
FDA 510(k)
FDA Class 2
·Dental
MX50N(MX50YQS)
FDA 510(k)
FDA Class 2
·Radiology
ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
FDA 510(k)
FDA Unclassified
·Unknown
IMPELLA CP
FDA Adverse Event
Death
·ABIOMED, INC.·Product code OZD·December 16, 2025
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·February 6, 2013
MESHGRAFT II COMPLETE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·December 16, 2010
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 15, 2014
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·August 12, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
CG COMPOSITE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 2, 2020
DURAN ANCORE RING
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 29, 2021
MONOCRYL UD 27IN USP2-0
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAN·October 25, 2024
MONOCRYL UD 27IN USP2-0
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAN·October 25, 2024
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 19, 2022
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012