12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OTC COMBO TENS/EMS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037091·Unitek(TM) Bicuspid Band General Purpose Wide U...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973578·
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 13, 2020
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXXENT RADIATION SHIELD - RIGID
FDA 510(k)
FDA Class 2
·Radiology
KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018
ADVIA CENTAUR XPT
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 19, 2016
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·June 3, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
640G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 9, 2015
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