11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JARVIS Glenoid Reverse Shoulder Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
Portex
FDA UDI
ICU MEDICAL, INC.·15019517110814·
MORELAND
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123316·MORELAND REV INST TREPHINE REAMER 14mm 5.5 IN
SLEEPSENSE SLEEP SENSORS
FDA 510(k)
FDA Class 2
·Anesthesiology
SOLSTICE OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 9, 2011
*
FDA Adverse Event
Malfunction
·REMINGTON MEDICAL, INC·Product code DSA·July 16, 2013
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024