9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXT 150M MANUAL COLLIMATOR (AXT 150M)
FDA 510(k)
FDA Class 2
·Radiology
ARGENCO 2 TYPE III DENTAL GOLD ALLOY
FDA 510(k)
FDA Class 2
·Dental
CMS-2000 Central Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·June 10, 1997
ASR ACETABULAR CUP 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 21, 2013
SMARTPUMP DUAL CHANNEL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KCY·August 1, 2014
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 28, 2011
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