12 results
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20ms
·
Sources: EU EUDAMED, US FDA
OPXION Optical Skin Viewer (OPXSV1-01F)
FDA 510(k)
FDA Class 2
·Radiology
BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·January 4, 2018
Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCHITECT STAT MYO IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 14, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 19, 2026
BIOCOR STENTED PORCINE HEART VALVE
FDA Adverse Event
Death
·ST JUDE MEDICAL BASIL LTDA.·Product code LWR·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 12, 2013
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·December 4, 2025
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 12, 2025
PKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014