11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HELENA FACTOR X DEFICIENT SUBSTRATE
FDA 510(k)
FDA Class 2
·Hematology
SpineWand
FDA UDI
MORGAN STEER ORTHOPAEDICS LIMITED·05060696460019·Perc DLG Convenience Pack inc 17 gauge 8” Crawf...
Coblation
FDA UDI
Smith & Nephew, Inc.·00817470004489·PERC DLG
ROUND FILTERS W/INDICATOR
FDA Adverse Event
Malfunction
·SPS MEDICAL·Product code FRG·February 28, 2014
Medsynapse Ris Pacs & Medsynapse VNA
FDA 510(k)
FDA Class 2
·Radiology
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FULL-SIZE LID W/RETENTION PLATE SILVER
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code FRG·March 10, 2016
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·May 6, 2014
TRUE2GO
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015
KAPPA 700 D
FDA Adverse Event
Injury
·MEDTRONIC, B.V.·Product code DXY·August 11, 2010
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