9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ENDOSCOPIC LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IN TEN-S
FDA 510(k)
FDA Class 2
·Dental
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
NXSTAGE SYSTEM ONE
FDA Adverse Event
Death
·NXSTAGE MEDICAL, INC.·Product code KDI·May 28, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·November 18, 2010
LAMITRODE TRIPOLE 16
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 28, 2012
12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·May 4, 2016
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