11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694482·LOCATOR Abutment Internal Hex. NP H6mm
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
FDA 510(k)
FDA Class 2
·Anesthesiology
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·July 23, 2019
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 22, 2013
LOW PROFILE SCREW, TI, 4.5 X 45MM, CANNULATED
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 27, 2011
GE OEC 6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 9, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 6, 2025
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015