9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
FDA 510(k)
FDA Class 2
·Cardiovascular
A1 SYSTEME 8201/2
FDA 510(k)
FDA Class 2
·Hematology
GRAMS ASPIRATOR S-300
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 12, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 2, 2012
ENDO GIA UNIVERSAL XL
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·September 22, 2010
PLATE GC LECT AGAR 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JTY·March 29, 2021
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018