26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3D ACTIVETRAC
FDA 510(k)
FDA Class 2
·Physical Medicine
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00171251·
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00171201·
Monster® Screw System
FDA UDI
Paragon 28, Inc.·00889795040404·Drill, 1.7 x 120mm, Solid, Trocar Tip, AO
Paragon 28
FDA UDI
Provision·B504OMP9910017120·
DIGITAL INTEGRATION SYSTEM, DIS2000
FDA 510(k)
FDA Class 2
·Radiology
PORTABLE INTENSIVE CARE UNIT, MODEL PIC
FDA 510(k)
FDA Class 2
·Anesthesiology
AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code PNJ·October 1, 2025
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FRN·April 14, 2025
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·March 6, 2013
EEA XL 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·February 22, 2011
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 15, 2008
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024
ALINITY M RESP-4-PLEX AMP KIT
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024