16 results
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19ms
·
Sources: EU EUDAMED, US FDA
PERCUTANEOUS TRACHEOSTOMY TUBE KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316111·Mini Sprint II Bracket FACE Evolution II System...
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029046036·UR CEN
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316111001·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316110051·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316110101·Mini Sprint II Bracket FACE Evolution II System...
P4-FITNESS
FDA 510(k)
FDA Class 2
·Physical Medicine
FRESENIUS DRY ACID DISSOLUTION UNITS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOLOX OPTION TAPER ADAPTER STD NECK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·August 9, 2018
UNKNOWN TM SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·October 9, 2018
UNKNOWN TRILOGY LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·October 9, 2018
BIOLOX DELTA OPTION CERAMIC HEAD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·August 9, 2018
CLP HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JDI·January 22, 2013
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA LLC·Product code LZS·December 7, 2010
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 14, 2014
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