9 results · 17ms · Sources: EU EUDAMED, US FDA

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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