43 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
FDA 510(k)
FDA Class 2
·Hematology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271753·
ZenFlex CM
FDA UDI
Kerr Corporation·00195062145766·ZenFlex CM .04/25mm ASSORTED PACK US/CAN
Conten...
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM
FDA 510(k)
FDA Class 2
·Dental
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
FDA 510(k)
FDA Class 2
·Microbiology
TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·TOTAL JOINT ORTHOPEDICS, INC.·Product code JWH·August 18, 2020
BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 6, 2023
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 1, 2024
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 26, 2024
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 23, 2024
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 40 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 21, 2021
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
STERNAL LOCK-PL 2.4 STRAIG 30HO TI
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·June 22, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·July 8, 2011
BALL HEADS: COCR 12/14 36 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 15, 2021
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 26, 2024
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2024
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 36
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 10, 2023
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 13, 2026