16 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIGNA Pioneer
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III
LEONE SPA
FDA UDI
LEONE SPA·08033707014577·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 3
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100271·SAUER INFANT SPECULUM
Arx
FDA UDI
Life Spine, Inc.·00190837124670·
Arx
FDA UDI
Life Spine, Inc.·00190837131432·
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DEPUY CMW 1, 2 AND 3 BONE CEMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
BD¿ FEMALE LUER LOCK ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 14, 2023
PROGAV®
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 8, 2013
VASOVIEW 7 XS
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 17, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 11, 2019
BD¿ FEMALE LUER LOCK ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 14, 2023
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