39 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PhotoFix Decellularized Bovine Pericardium
FDA 510(k)
FDA Class 2
·Cardiovascular
PHOTOFIX PATCH - 6CM X 8CM
FDA Adverse Event
Injury
·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
FDA 510(k)
FDA Class 2
·Anesthesiology
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 1, 2023
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 14, 2021
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2021
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
BEND-SCR F/UNILOCK-RECOPL TI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2011
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 3, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 8, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 4, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 7, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 15, 2022
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 25, 2026
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 1+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 22, 2020
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 24, 2020
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 4, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 17, 2022