41 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575685·CoRoent Ant TLIF Ti, 16x11x36mm 8°
DIAGNOSOFT HARP
FDA 510(k)
FDA Class 2
·Radiology
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
5.0CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 11, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 13, 2011
PROLIEVE THERMODILITATION KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·April 20, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·April 17, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC.·Product code KRD·April 3, 2026
Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·April 24, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION INC.·Product code KRD·January 14, 2025
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code HCG·May 28, 2026
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·October 16, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION INC.·Product code KRD·September 15, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Injury
·MICROVENTION, INC·Product code HCG·May 2, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVERSION, INC.·Product code KRD·February 28, 2024
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·June 2, 2023