42 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
FDA 510(k)
FDA Class 2
·Microbiology
Clear Readers
FDA UDI
Diversified Products, Inc.·00037741113171·
Biogel
FDA UDI
Bosma Enterprises·10818634023688·Biogel Indicator Underglove Surgical 7.5 - 50 P...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450190012·
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894113868·
VuMesh™
FDA UDI
Seaspine Orthopedics Corporation·10889981036669·End Cap (10mm Cage) 12mm, 7.5 Deg
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
FDA 510(k)
FDA Class 2
·General Hospital
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).
FDA 510(k)
FDA Class 2
·Cardiovascular
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 5, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 6, 2019
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·October 1, 2014
ACETABULAR SHELL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HRS·May 9, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 5, 2019
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 7, 2025
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 19, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·June 20, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 2, 2020