9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
IMC SALINE WET DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Ventura NanoMetalene System
FDA UDI
Seaspine Orthopedics Corporation·10889981152253·Ventura NM Trial, 11mm x 32mm x 13mm, Lordotic
ATOVEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CT-MASS
FDA 510(k)
FDA Class 2
·Radiology
ENCOR BREAST BIOPSY PROBE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KNW·April 3, 2014
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 29, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 16, 2010
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015