16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VACUTAINER BRAND CTAD TUBE (MULTIPLE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD VACUTAINER® CTAD BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 4, 2018
BD VACUTAINER® CTAD BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 31, 2018
BD VACUTAINER® CTAD BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 3, 2018
XCALIBER BONE SCREWS
FDA UDI
ORTHOFIX SRL·18054242512646·BONE SCREW HAND DRILL STERILE
MEDPOR CONTAIN IMPLANT
FDA 510(k)
FDA Class 2
·Dental
MIDDLE EAR PICKS, HOOKS CURETTES,
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 6, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024
INDEFLATOR
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 20, 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
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024