7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES
FDA 510(k)
FDA Class 1
·Dental
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
FDA 510(k)
FDA Class 2
·Neurology
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 8, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
CRANIOTOME BLADE, NEURO 1.8 X 29.2MM
FDA Adverse Event
Malfunction
·CONMED LINVATEC·Product code HWE·May 7, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024