17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114278·CHAMBER MAINTAINER 20GA (PK/10)
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
Acumed Small Bone IM Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·December 20, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·December 23, 2024
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·December 20, 2024
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·December 23, 2024
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 11, 2014
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·September 1, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 23, 2013
SL 1 INTRODUCER UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011
RESPONSE EP CATHETER UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011
NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·December 19, 2024
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