17 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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EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet
FDA UDI
Bard Access Systems, Inc.·00801741013836·EQUISTREAM XK HEMODIALYSIS CATH w/STYLET, ST, A...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613023775·Metzenbaum Scissors, Straight, Blunt Tips, Oval...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776098599·Beckman Lamin Retractor,
TRU LEGIONELLA
FDA 510(k)
FDA Class 2
·Microbiology
BD PureHub Disinfecting Cap
FDA 510(k)
FDA Class 2
·General Hospital
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 27, 2014
EQUIPO DE EXTENSI?N PARA ANESTESIA
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code FPA·December 2, 2010
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 14, 2013
EQUISTREAM XK CATHETER
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code MSD·April 18, 2019
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·June 10, 2020
ARCOM XL 44-36 STD HMRL BRNG
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code PAO·September 7, 2017
EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code MSD·June 14, 2019
COMP RVS TRAY CO 44MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code KWS·September 7, 2017
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·September 4, 2019
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019
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