18 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEMORY STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
FDA 510(k)
FDA Class 2
·Cardiovascular
BIRD TBIRD VELA VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·July 26, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 26, 2019
UNKNOWN NOTTINGHAM SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBF·May 17, 2017
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 21, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·April 24, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·October 3, 2019
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
OLYMPUS THUNDERBEAT 5MM, 45CM, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·March 29, 2013
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·June 11, 2008
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 8, 2011
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 23, 2019
COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HSD·October 19, 2016
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·March 28, 2019
ULTRASAFE X100L PR GREY SSL SDZ
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 11, 2019
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018