10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
NA
FDA UDI
KEY SURGICAL, INC.·10849771049880·Steinmann Pins, Single diamond, 3 shank end, 3/...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293722·
NuVasive TLX Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
LANX DEFORMITY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LOGIC CR TIB INSERT SLOPE +, SZ 2.5, 9 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 10, 2024
FIXED CEILING LIFT
FDA Adverse Event
Malfunction
·PRISM MEDICAL·Product code FNG·February 11, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 27, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 31, 2014
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017