11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ziehm Solo FD
FDA 510(k)
FDA Class 2
·Radiology
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Medical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 6, 2025
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 19, 2025
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·November 11, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 24, 2011
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 23, 2013
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026
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
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025