14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wesper Lab
FDA 510(k)
FDA Class 2
·Anesthesiology
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038608·
ORGANOGENESIS INC.
FDA registration
ORGANOGENESIS INC.·5 products·🇺🇸 United States
DMI
FDA UDI
D-M-S HOLDINGS, INC.·00041298524113·BARIATRIC BATH SEAT W/BACK
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038615·
ARTHROTAP
FDA 510(k)
FDA Class 2
·General Hospital
SENSUS ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
GLOVE, EXAM, ALOETOUCH 3G, PF SY
FDA Adverse Event
Other
·MEDLINE INDUSTRIES, INC.·Product code LYY·October 30, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 18, 2011
APERFIX FEMORAL IMPLANT WITH INSERTER
FDA Adverse Event
Other
·CAYENNE MEDICAL, INC.·Product code HWC·July 9, 2013
PURAPLY ANTIMICROBIAL WOUND MATRIX
FDA Adverse Event
Injury
·ORGANOGENESIS·Product code FRO·April 6, 2018
PURAPLY ANTIMICROBIAL WOUND MATRIX
FDA Adverse Event
Injury
·ORGANOGENESIS·Product code FRO·April 6, 2018
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025