12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPTUS LARYNGOSCOPES
FDA 510(k)
FDA Class 1
·Anesthesiology
PACING/PSI KIT: 5 FR/6 FR 2-L
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015
OCHSNER 500 VASCULAR PROSTHESIS
FDA 510(k)
FDA Class 2
·Cardiovascular
HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
10 LEAD ECG TRUNK AAMI/IEC 2M
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSA·May 6, 2014
COLLAMER ULTRAVIOLER-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·December 21, 2010
HANDLE-IMAS PEDICLE SCOPE
FDA Adverse Event
Malfunction
·SYNTHES (USA) BRANDYWINE·Product code FZX·February 1, 2013
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿)
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·July 15, 2022
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿), PLATE, 90 MM X 120
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·March 29, 2022
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
FDA Enforcement
Class II
·Terminated·CareFusion 303, Inc.·March 30, 2016
PLATE CHOCO GC AGAR W/ISOVITALEX 90MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·June 1, 2021
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