8 results · 18ms · Sources: EU EUDAMED, US FDA

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GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AIA-PACK HGH

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MODELS M1722A, M1723A, M1724A DEFIBRILLATORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·January 2, 2013

GYNECARE X-TRACT MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·December 16, 2010

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·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