17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Telescope Guide Extension Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575177677·UHMWPE Inserts -X-LINKed; Standard (Neutral)
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575177684·UHMWPE Inserts -X-LINKed; Standard (Neutral)
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575177660·UHMWPE Inserts -X-LINKed; Standard (Neutral)
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSURE(R) PS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DISCOVERY MR450
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code LNH·April 4, 2012
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·December 6, 2021
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·June 21, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 28, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EYB·July 2, 2024
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·February 28, 2022
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code EZL·July 8, 2022
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·January 15, 2021
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