11 results
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18ms
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Sources: EU EUDAMED, US FDA
SUNLITE LARYNGOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123823·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 75mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123090·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 75mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122925·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 150mm
TAPER SET HIP SYSTEM RDP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO SPARC SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 6, 2023
KAPPA 700 DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 17, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 2014
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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