17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO BEACON STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198819·AK3 Ultra Insert Trial Size 6, 10mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450281703·
Spine Innovation Interbody System
FDA UDI
SPINE INNOVATION, LLC·00817722020076·Expandable Implant 0° x 9mm W x 10mm H x 26mm L
MODIFIED SONAMET BODY COMPOSITION ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BDRV CANN SCW SS P/T DIA4.5X60MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017
BDRV CANN SCW SS P/T DIA4.5X52MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017
FINN YOKE STD REINFORCED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·October 5, 2021
FINN ROTATING HINGED KNEE TIBIAL BEARING 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·October 5, 2021
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 3, 2013
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·September 4, 2014
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Injury
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·May 4, 2011
PENTAX
FDA Adverse Event
Injury
·HOYA CORP.·Product code FDT·July 24, 2015
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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