17 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
FDA 510(k)
FDA Class 2
·Orthopedic
NIH™
FDA UDI
MEDTRONIC, INC.·00613994964854·WVN CATH 001378 10PK 5442 5 80 PEDAT NH
NIH™
FDA UDI
MEDTRONIC, INC.·00763000199357·WVN CATH 001378 10PK 5442 5 80 PEDAT NH
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001378·artVeneer life upper anteriors, IM, C3
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450157282·
SMR SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·January 19, 2026
SoftTip® medium
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616002530·SoftTip® medium RM-3512-9 Datex
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
BACT/ALERT MB CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·March 13, 2013
COBAS E411 DISK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·February 25, 2011
NA
FDA Adverse Event
Malfunction
·ASCENT HEALTHCARE SOLUTIONS·Product code DQO·February 20, 2008
DAR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CAH·October 2, 2025
MI-750
FDA Adverse Event
Malfunction
·MEDICAL ILLUMINATION INTRNATION INC.·Product code FSY·January 17, 2023
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
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
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