16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
CMDR 2C (Multiple Models)
FDA 510(k)
FDA Class 2
·Radiology
Dynarex Eye Cups
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·June 1, 2023
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 3, 2023
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Death
·INSULET CORPORATION·Product code LZG·July 19, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014
TRIAGE TOX DRUG SCREEN WITH MTD
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code DJR·August 10, 2011
BLACKMAX-NEURO
FDA Adverse Event
DEPUY SYNTHES POWER TOOLS·Product code HBB·July 29, 2013
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·December 13, 2023
OMNIPOD DASH, PODS 10-PACK
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 9, 2023
OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·January 23, 2024
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 21, 2022
OMNIPOD 5 POD
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·July 11, 2023
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·April 17, 2023