19 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361013037·PedFuse Remind LES, Quad-H, 7.0mm x 50mm
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033519097·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033519110·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033519158·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033519127·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033519103·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033519134·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033519141·
POLESTAR N-10
FDA 510(k)
FDA Class 2
·Radiology
RECORDING AND STIMULATING ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013
CELL-DYN 1700 ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·March 10, 2011
EMBOSHIELD EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NTE·March 14, 2008
SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·April 2, 2019
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 2, 2019
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023