18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3181 DUO DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Preat
FDA UDI
Preat Corporation·00842092170687·ASC NobelActive™/Conical-compatible RP X 9mm En...
PowerPICC Provena SOLO
FDA UDI
Bard Access Systems, Inc.·00801741202070·Catheter Placement Kit
AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143912092·LAA Exclusion System, PRO250
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214377·Cassettes are designed to contain incised tissu...
AtriClip® LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143900204·AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion ...
AtriClip® LAA Exclusion System
FDA UDI
ATRICURE, INC.·10840143907470·AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion ...
AtriClip® LAA Exclusion System
FDA UDI
ATRICURE, INC.·00818354015065·AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion ...
COMPUMEDICS E-SERIES EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOSAVE HYBRID, TYPE I PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 4, 2025
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013
HEALIX BR ANCHOR W/ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·February 18, 2011
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·February 15, 2008
ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR
FDA Adverse Event
Malfunction
·KESTRA MEDICAL TECHNOLOGIES, INC.·Product code MVK·November 19, 2025
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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