14 results · 22ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO: OCU-FILM TIP COVER

FDA 510(k)
FDA Class 2 ·Ophthalmic

LYNX

FDA UDI
HNM TOTAL RECON LLC·00841742111438·LYNX ø4.0mm Cancellous Screw, Full Thread, Ti -...

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

FDA 510(k)
FDA Class 2 ·Immunology

CROSS-CHECKS DUAL, MODEL CI 125

FDA 510(k)
FDA Class 2 ·General Hospital

VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

VKMO 78000 #QUADROX-I HMO 70000+VHK7000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

LINEAR 3-6

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 5, 2020

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 16, 2025

WAVEWRITER ALPHA? PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 24, 2025

HLM TUBING SET W/SOFTLINE COATING

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 17, 2013

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·March 29, 2011

TUBE, GASTROINTESTINAL (AND ACCESS)

FDA Adverse Event
Malfunction ·C. R. BARD INC. (BASD)·Product code KNT·July 2, 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