21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Microlife Upper Arm Automatic Digital Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111076169·SKLHN GORNEY SCISS STR 7 1/4"
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE
FDA 510(k)
FDA Class 2
·Dental
153-450
FDA Adverse Event
Injury
·SANTA BARBARA·Product code FTR·January 25, 2006
153-450
FDA Adverse Event
Injury
·SANTA BARBARA·Product code FTR·January 25, 2006
HUMAPEN ERGO 3 ML
FDA Adverse Event
Injury
·ELI LILLY AND CO.·Product code KZE·November 1, 2002
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 8, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 7, 2011
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·September 5, 2008
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
DYB INTRODUCER, CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 12, 2025
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Injury
·COOK INC·Product code DYB·October 29, 2025
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020
FLEXOR SHUTTLE SELECT GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 7, 2020
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
FDA Enforcement
Class II
·Ongoing·Abbott·November 8, 2023
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023