20 results
·
74ms
·
Sources: EU EUDAMED, US FDA
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 5, 2010
ACCU-CHEK® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 29, 2010
RELAY PRO THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·November 7, 2025
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 14, 2022
RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·February 12, 2025
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·October 14, 2022
RELAY PRO THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·April 11, 2023
RELAY PRO THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL INC.·Product code MIH·May 30, 2023
GORE® VIABAHN® ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·July 24, 2025
R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code NIP·February 23, 2023
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·March 10, 2026
GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code PRL·May 13, 2024
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·January 17, 2025
NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.
FDA Recall
Terminated
·Teco Diagnostics·Product code KQO·October 1, 2010
GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·April 19, 2024
GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code NIP·December 19, 2025
GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code PRL·February 3, 2025
RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·March 19, 2026
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
FDA Recall
Terminated
·Cook Inc.·Product code DQO·April 15, 2016
Emergo Europe B.V.
Authorized representative
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