9 results
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17ms
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Sources: EU EUDAMED, US FDA
HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT
FDA 510(k)P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295244950·P.F.C. SIGMA STABILIZED PLUS TIBIAL INSERT TRIA...
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
FDA 510(k)
FDA Class 2
·Microbiology
BENZ-G 4X HIOXIFILCON D
FDA 510(k)
FDA Class 2
·Ophthalmic
LARGE HEXAGONAL SCREWDRIVER LONG
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·August 18, 2020
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 13, 2014
HELICAL BLADE COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·February 14, 2013
SCULPTRA (POLY-L-LACTIC ACID)
FDA Adverse Event
Injury
·SANOFIAVENTIS U.S. LLC·Product code LMH·January 13, 2011
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