15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISTAL ACCESS TORQUE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...
Batrik Pin Guard\.054"\Dark Red
FDA UDI
Batrik Medical Manufacturing Inc·00690521012851·Pin Guards, 0.054" (1.40 mm), Dark Red, Non-ste...
RECAP/MAGNUM HIP INSTRUMENTATION
FDA UDI
Biomet Uk Ltd·05019279108237·
Batrik Pin-Kaps
FDA UDI
Batrik Medical Manufacturing Inc·00690521014145·Pin-Kaps, Sterile, Dark Red, 0.054" / 1.40 mm
Batrik Pin Guard\.054"\Dark Red w/sleeve
FDA UDI
Batrik Medical Manufacturing Inc·00690521014541·Pin Guards, 0.054" (1.40 mm), Dark Red, Non-ste...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106400·Porous Acetabular Cup System - Hemispherical Sh...
MEDLINE STRIDER MAXI 3
FDA 510(k)
FDA Class 2
·Physical Medicine
ROMIAPEX MODEL A-15
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2024
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 16, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·August 29, 2008
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026