9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Parietene Macroporous Mesh (PPM5050 )
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813036112·C-FILE 25MM #10
MODIFICATION TO ABL800 FLEX
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Checkme Pro Health Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
*
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS, INC.·Product code LJS·September 7, 2011
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FMF·November 26, 2008
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 29, 2013
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y
FDA Enforcement
Class I
·Terminated·Applied Medical Resources Corp·May 13, 2020
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