35 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEXIPLIANT DILATOR SHEATH SET
FDA 510(k)
FDA Class 2
·Cardiovascular
KneeAlign 2
FDA UDI
Orthalign, Inc.·00858704006008·KneeAlign 2 Unit
KneeAlign 2
FDA UDI
Orthalign, Inc.·00810832031376·KneeAlign 2 Unit
MODIFICATION TO COATEST FACTOR VIII
FDA 510(k)
FDA Class 2
·Hematology
SLEEPMINDER BREATHING FREQUENCY INDICATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
TPRLC XR T1 PPS 17X154MM MM T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code OQG·February 25, 2020
TPRLC XR T1 PPS 14X148MM MM T1
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code OQG·February 25, 2020
TPRLC 133 FP TYPE1 PPS SO 5.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code OQG·February 25, 2020
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
UNKNOWN ZIMMER KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 16, 2011
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·August 20, 2008
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015
FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018
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