32 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpeediCath Compact Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PATHWAY IVB/VBR
FDA 510(k)
FDA Class 2
·Orthopedic
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·February 22, 2021
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025
DAMON COPPER NITI WIRE
FDA Adverse Event
Malfunction
·ORMCO CORPORATION·Product code DZC·October 10, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
AUTOCAT 2
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·July 25, 2011
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDX·January 6, 2022
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·October 25, 2021
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FDX·May 4, 2022
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FDX·November 14, 2022
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·August 27, 2024
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·July 31, 2024