50 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sofia RSV FIA on Sofia 2 analyzer
FDA 510(k)
FDA Class 1
·Microbiology
CEMENTED HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254138·
FETAL DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VERSAFITCUP CC TRIO EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
VERSAFITCUP CC TERMINAL CUP IMPACTOR
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MEH·June 4, 2014
NA
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 4, 2014
ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2018
VERSAFITCUP CC HIGHCROSS PE LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 31, 2013
VERSAFITCUP FLAT PE HC LINER Ø 36 / E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·April 26, 2017
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·October 10, 2014
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 13, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017
STEM: AMISTEM H HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 11, 2019
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).
FDA Enforcement
Class III
·Terminated·ECOLAB INC·July 11, 2018
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 5, 2024
VERSAFITCUP FLAT PE HC LINER Ø 32/E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2016
STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·February 28, 2020
AMISTEM H CEMENTLESS STEM #4 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MEH·February 9, 2015
CUP: VERSAFITCUP ACETABULAR SHELL 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 3, 2020