28 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799387·MANUMED ACTIVE WRIST LEFT SAND XS
Pathway
FDA UDI
SPINAL ELEMENTS·00840916129576·Pathway ELIF Small 11mm
CASTROVIEJO SUTURE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896073579·CASTROVIEJO SUTURE FORCEPS WITH LOCK
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613109202·Goodhill Ear Forceps, 5mm Serrated Jaws, Shaft ...
AOS ORION IR-192 SOURCE CABLE
FDA 510(k)
FDA Class 2
·Radiology
VIVOSORB SHEET, MODEL FS01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·March 4, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 24, 2013
LIFESTENT VASCULAR STENT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIP·September 23, 2014
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·June 21, 2011
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
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 29, 2020
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
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 12, 2018
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 19, 2021
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 15, 2020