15 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SNOWDEN-PENCER INSUFFLATOR TUBING SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909138352·REVELATION DIAMOND 885-014SC - 5 PACK
DATACAPTOR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GLOBAL HEALTHCARE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
D901 LILLIPUT OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·October 13, 2021
PERFORATOR BIT LARGE 14/11MM
FDA Adverse Event
Injury
·STRYKER IRELAND LTD.·Product code HBF·November 29, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
PRIME BIG WHEEL STRETCHER, 30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·November 20, 2012
CUSTOM PERFUSION PACK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 30, 2012
LILLIPUT 1 START
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 17, 2023
LILLIPUT 1 OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code DTZ·December 27, 2024
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 6, 2024
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·January 17, 2022
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·January 25, 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