9 results
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19ms
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Sources: EU EUDAMED, US FDA
RHINO-LARYNX STROBOSCOPE TYPE 4914
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
REBOSSIS
FDA 510(k)
FDA Class 2
·Orthopedic
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
FDA 510(k)
FDA Class 2
·Anesthesiology
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 31, 2014
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·November 21, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 20, 2010
1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOP
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HBE·September 15, 2020
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS; 6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT; 7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA; 8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA; 9) Left Heart Kit, Catalog Number SAN73LHKCC; 10) Left Heart Kit, Catalog Number SAN73LHKC6
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017