24 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION C4 FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Immunology
MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 25, 2018
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·June 18, 2013
ZEPHIR® ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·April 10, 2015
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·November 24, 2017
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·July 12, 2011
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2022
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·November 20, 2009
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 10, 2022
TRINKLE QUICK-COUPL DRILLING SPEED MODIF
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 8, 2013
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 8, 2014
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code FOZ·January 14, 2011
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 3, 2012
ZEPHIR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·May 15, 2013
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·January 19, 2018
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·January 19, 2018
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 8, 2017
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·November 15, 2016