17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984022·anteriors; shade A1; mould D 82
PROCARE
FDA UDI
DJO, LLC·00190446660309·ARM SLING, CTN/POLY XSM
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k)
FDA Class 1
·General Hospital
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 27, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 27, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 18, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPAEDIC INC.·Product code KWP·October 8, 2009
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 28, 2013
TARGET DEVICE, HUMERUS
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·January 14, 2011
INST OIL W/ FILTER, AL-II/III
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·December 18, 2013
BURN AID
FDA Adverse Event
Malfunction
·RYE PHARMACEUTICALS PTY. LTD.·Product code MGQ·April 18, 2000
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