13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
FDA 510(k)
FDA Class 2
·General Hospital
ELMED
FDA UDI
ELMED INCORPORATED·00842180124455·5 MM DIA., 36 CM INSULATED J-HOOK TIP ELECTRODE...
LINER F. MET.BACK GLEN.SMALL-R
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·April 5, 2019
SSA-770A, APLIO ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MCKESSON ANESTHESIA CARE
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·August 16, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 25, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
Phoenix AP AST Indicator Bag, Catalog Number 246006
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 6, 2019
CustMbite, Model Number CBT-SRS-UL
FDA Enforcement
Class II
·Ongoing·Dental Choice Holding Llc·August 10, 2022
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025