20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Straumann BLX Surgical Cassette
FDA 510(k)
FDA Class 2
·General Hospital
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
FDA 510(k)
FDA Class 2
·Radiology
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
FDA 510(k)
FDA Class 2
·Orthopedic
DRILL GUIDE FOR DIAM 3.5 SCREW
FDA Adverse Event
Malfunction
·INTEGRA, SAINT PRIEST·Product code HTW·July 7, 2011
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 20, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 22, 2008
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 30, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 22, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 22, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·March 11, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·March 4, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·February 1, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·March 11, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·December 2, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·December 2, 2021
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014