18 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROGRIP LAPARSCOPIC SELF-FIXATING MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ArgenPMMA 98x25-B4
FDA UDI
ARGEN CORPORATION, THE·D818120897·Crown And Bridge, Temporary, Resin
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720417·Green Tissue Forceps 4" (10cm), T-shape, 5mm wi...
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400
FDA 510(k)
FDA Class 2
·Cardiovascular
LEGION POROUS + HA TIBIAL BASEPLATES
FDA 510(k)
FDA Class 2
·Orthopedic
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 8, 1997
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 8, 1997
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2018
COULTER® LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 20, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 26, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 12, 2011
EAGLE EYE PLATINUM SHORT TIP
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER
FDA Adverse Event
Injury
·VOLCANO CORPORATION·Product code OBJ·July 1, 2016
BD INSYTE AUTOGUARD CATETER I.V. 20G X 1.16
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·October 20, 2020
INSYTE AUTOGUARD PNK 20GA X 1.16IN
FDA Adverse Event
Injury
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 2, 2020
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 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