19 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POD SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052025366·Full Radius Resector 3,5
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024334687·
Ardis®
FDA UDI
ZIMMER SPINE, INC.·00889024333956·
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
FDA 510(k)
FDA Class 1
·Ophthalmic
COMBOMAP PRESSURE AND FLOW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025
AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024
AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024
AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026
AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE
FDA Adverse Event
Malfunction
·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 26, 2020
SHEATH, 2.9MM OPERATIVE INNER
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code HIH·October 3, 2014
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 22, 2011
NV GXL LNR, LIPPED 32MM ID GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 26, 2024
VIDAS TSH
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·November 25, 2020
VIDAS HCG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JHI·August 19, 2021