17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACFIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450637753·
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033518168·
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033518175·
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033518137·
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033518151·
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033518144·
TO BE ASSIGNED
FDA UDI
FGX INTERNATIONAL INC.·00193033518182·
AVALON CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INSULIN PEN NEEDLE ADAPTER
FDA 510(k)
FDA Class 2
·General Hospital
HEART-VALVE, REPLACEMENT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·March 20, 2013
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·March 10, 2011
GUIDANT VASOVIEW HEMOPRO
FDA Adverse Event
Injury
·GUIDANT CARDIAC SURGERY·Product code GEI·March 14, 2008
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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