16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Disposable Medical Face Mask (ear loop)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD BBL™ Fluid Thioglycollate Medium
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902211960·BD BBL™ Fluid Thioglycollate Medium, 8 mL, Cart...
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
FDA 510(k)
FDA Class 2
·Cardiovascular
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
FDA 510(k)
FDA Class 2
·Neurology
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·January 2, 2024
BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·July 15, 2022
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·November 3, 2014
DISSECTOR, 4.0MM X 13CM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code GFA·August 24, 2011
OLYMPUS EVIS EXERA XENON VIDEO SYSTEM CENTER
FDA Adverse Event
Death
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KOG·July 3, 2013
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·March 20, 2023
BD BBL¿ FLUID THIOGLYCOLLATE MEDIUM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·March 8, 2023
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 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