9 results
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18ms
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Sources: EU EUDAMED, US FDA
POWERMATIC EXAMINATION TABLE
FDA 510(k)
FDA Class 1
·Physical Medicine
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
CLYDESDALE(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CUTTER FOR TI ELASTIC NAILS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTZ·September 17, 2019
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 21, 2012
PFC SIGMA CRVD INSERT SZ5 8MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 17, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014
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