44 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Closed Wound Suction
FDA UDI
C. R. Bard, Inc.·00801741050039·100cc Silicone Closed Wound Suction Evacuator K...
CM-hex screw system
FDA UDI
Cendres+Métaux SA·07640173091356·CM-hex screw system
Mounting screw X (M1.4)
F-11 FOLDING POWER CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO CLEARFIL LINER BOND 2V
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DTK·August 21, 2014
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 14, 2023
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 20, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·August 20, 2014
8.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·April 23, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2011
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008
Vanguard XP Tibial Tray 83 mm Item # 195253
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·April 3, 2026
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·September 12, 2017
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 11, 2021
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·December 5, 2017
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 4, 2025
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·June 4, 2019
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·May 21, 2019