40 results
·
23ms
·
Sources: EU EUDAMED, US FDA
BinaxNOW G6PD Test
FDA 510(k)
FDA Class 2
·Hematology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575678·CoRoent Ant TLIF Ti, 16x11x36mm 4°
LANX FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
PILOT POSTERIOR LUMBAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2024
NITREX® GUIDEWIRE
FDA Adverse Event
Injury
·EV3 INC.·Product code DQX·July 13, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·June 11, 2013
CORFLO CUBBY DUAL PORT STANDARD BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·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
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, 10FR W/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