10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TUBE-STAT
FDA 510(k)
FDA Class 1
·Anesthesiology
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
VERTA Corpectomy Cage
FDA 510(k)
FDA Class 2
·Orthopedic
VNGD ANT STBLZD BRG 10X71
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 7, 2019
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 14, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·November 19, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - VASCULAR SOLUTIONS·Product code MGB·September 22, 2010
BIOMET CC CRUCIATE TRAY 71MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 11, 2019
VANGUARD CR ILOK FEM-RT 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 11, 2019
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