20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROMEDICS SPHENOID SINUS STENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Asst Silver Cart
FDA UDI
Engle Dental Systems, LLC·00850043433118·Assistant's cart with table top
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306813061·Reynolds Tenotomy Scissors, Straight, 15cm
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981173067·L Con, Side-Loading, R, 8mm, 340mm
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
HYSTALOG HSG CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
Widex
FDA UDI
Widex A/S·05706069686951·Widex EVOKE E-IP (Light beige ) 440, Left
Widex
FDA UDI
Widex A/S·05706069686975·Widex EVOKE E-IP (Dark brown ) 440, Left
Widex
FDA UDI
Widex A/S·05706069686968·Widex EVOKE E-IP (Clay brown ) 440, Left
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 3, 2025
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 13, 2006
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 8, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 12, 2011
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Injury
·CARDINAL HEALTH ALARIS PRODUCTS·Product code FPA·May 23, 2008
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