17 results
·
23ms
·
Sources: EU EUDAMED, US FDA
CSF-3
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517300195·CoRoent® XLK, 12x18x60mm 10°
CoRoent
FDA UDI
Nuvasive, Inc.·00887517287809·CoRoent® XL-CTW, 12x22x60mm, 10°
Wet-Field® Eraser®
FDA UDI
Beaver-Visitec International, Inc.·30886158010495·20 GA Blunt Tip
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024400566·
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123204410·TC BERRY STERNAL NH 7-1/4
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046514·LATERAL TRIAL, WIDE, STANDARD, 12mm X 23mm X 60mm
TROOPER OXYGEN CONCENTRATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G7 DUAL MOBILITY LINER 46MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OQG·February 8, 2022
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 5, 2008
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·August 17, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
VIVACIT-E DM BEARING 28X46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·February 8, 2022
ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code FOZ·October 16, 2017
CER BIOLOXD OPTION HD 28MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·February 8, 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