39 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HawkOne Directional Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
REEFLEX PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
FDA 510(k)
FDA Class 2
·Radiology
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 13, 2021
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code NVN·October 10, 2014
M2A-MAGNUM MOD HD SZ 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2013
UTERINE MANIPULATOR - 7CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LKF·July 13, 2011
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
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
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. 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 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
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code KRD·May 8, 2026