22 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GENESIS REUSABLE RIGID CONTAINER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
APEX™
FDA UDI
B. BRAUN MEDICAL INC.·04046964539282·EVA Dual-Chamber Final Containers 3000 mL
Unity
FDA UDI
DIOMEDICAL CO.,LTD.·08800039821308·SIJ Standard Thread OD12.5xL35
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014631349·SurgyCut J - Wire Hand Control Electrode, 5mm/35cm
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
DRG DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011
STONYBROOK HSP NY NY 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 14, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
DELTA LINERS & ACCESSORIES
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code LPH·March 6, 2026
C21785 IT TREVISO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code GEI·December 14, 2012
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 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