50 results
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35ms
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Sources: EU EUDAMED, US FDA
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall
Terminated
·Sarken, Inc.·Product code DJG·July 29, 2013
SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall
Terminated
·Sarken, Inc.·Product code DIO·July 29, 2013
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall
Terminated
·Sarken, Inc.·Product code DIO·July 29, 2013
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall
Terminated
·Sarken, Inc.·Product code DKZ·July 29, 2013
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall
Terminated
·Sarken, Inc.·Product code LDJ·July 29, 2013
SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Recall
Terminated
·Sarken, Inc.·Product code DKZ·July 29, 2013
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
ASCENT PRIMARY TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET, INC.·Product code JWH·July 15, 2008
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 6, 2026
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·February 11, 2026
VIAL2BAG ADVANCED® 20MM ADMIXTURE DEVICE
FDA Adverse Event
Malfunction
·WEST PHARMACEUTICAL SERVICES AZ, INC.·Product code LHI·August 20, 2025
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 25, 2023
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 14, 2024
NEUROSTAR TMS THERAPY
FDA Adverse Event
Injury
·NEURONETICS, INC.·Product code OBP·June 3, 2022
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·December 5, 2025