8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
FDA 510(k)
FDA Class 2
·Dental
1BD SOLOSHOT IX SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 26, 2026
PROLIEVE THERMODILATATION KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·November 21, 2008
FORTIFY VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
33CM DORSEY GRASPER FORCEPS, P/N 0250080319. 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