24 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 6416 TEMPORARY PACING LEAD SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
20GA Illuminating Laser Probe, SMA905
FDA UDI
Peregrine Surgical, Llc·00632307002045·20GA Illuminating Laser Probe, SMA905
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AOS MODULAR FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·May 11, 2018
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019
TRIAGE D-DIMER TEST
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·October 2, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·September 17, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·May 7, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·August 17, 2018
M2A ACETABULAR CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·June 28, 2018
BI-METRIC FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MEH·June 28, 2018
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·April 4, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·March 28, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
BI-METRIC/X POR NC 17X165
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MEH·March 13, 2018
M2A ACETABULAR CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 13, 2018
ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 10, 2024
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·August 8, 2023