40 results · 23ms · Sources: EU EUDAMED, US FDA

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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