12 results
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19ms
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Sources: EU EUDAMED, US FDA
COAG-A-MATE MTX
FDA 510(k)
FDA Class 2
·Hematology
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295244981·P.F.C. SIGMA STABILIZED PLUS TIBIAL INSERT TRIA...
FRANKLIN CHAIRS/MOVES, #4000 SERIES & #4100 SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
KLS MARTIN QUICK DISC
FDA 510(k)
FDA Class 2
·Neurology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·May 7, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·October 12, 2022
XENIUM XPM
FDA Adverse Event
Malfunction
·NIPRO CORPORATION *USD*·Product code KDI·February 14, 2013
TRIATHLON PS PRECISION FEMORAL PREP KIT SIZE 4
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 22, 2010
EVITA INFINITY
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL, INC.·Product code CBK·July 17, 2014
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
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