13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO ORIA TOP CLIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201502747·FIXATION SCREW 60 MM, TITANIUM
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101543·SS Suture, 6 per sleeve
EZ CONNECT
FDA 510(k)
FDA Class 2
·Dental
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 8, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 15, 2011
LADAR WAVE CUSTOM CORNEA WAVEFRONT SYSTEM
FDA Adverse Event
Injury
·Product code LZS·May 7, 2008
6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013