26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
FDA 510(k)
FDA Class 2
·Radiology
AGXO
FDA UDI
Oticon A/S·05707131261182·H100, MINIRITE 312 WL DBL AGXO
WESTCOTT TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014558·WESTCOTT TENOTOMY SCISSORS STRAIGHT BLUNT BLADES
ADDplus
FDA UDI
Ulrich GmbH & Co. KG·04052536007318·Screwdriver, hex 2.5 mm, AO-coupling
K133801
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
FDA 510(k)
FDA Class 2
·Anesthesiology
ORTHO-1(NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Other
·INSULET CORPORATION·Product code LZG·January 16, 2009
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
UNIDENTIFIED HIP IMPLANT OR INSTRUMENT
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 29, 2013
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 14, 2011
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014
ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·August 30, 2016