11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V-STRUT Vertebral Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Twin gas bottle holder
FDA UDI
VISIONSENSE LTD.·10813040013766·
ARSENAL PETITE LAPIDUS PLATE, R
FDA Adverse Event
Injury
·TRILLIANT SURGICAL·Product code HRS·April 3, 2020
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
FDA 510(k)
FDA Class 2
·General Hospital
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 2, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 22, 2014
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 26, 2013
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code LFL·July 1, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018