47 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MAGiC
FDA 510(k)
FDA Class 2
·Radiology
TITAN TI SUTURE ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
ENRHYTHM MRI
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·October 10, 2014
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 11, 2013
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·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
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 10, 2025
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 Silicone Flat Drain, 7mm, 3/4 Ducts. 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
COOK® SINGLE-USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·May 17, 2019
AZUR SOFT3D DETACHABLE 10
FDA Adverse Event
Malfunction
·MICROVERSION, INC.·Product code KRD·February 28, 2024