10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Arthrex iBalance TKA System
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
FDA 510(k)
FDA Class 2
·Dental
FLEXIBLE SILICONE DRILL DRIVER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HTW·August 3, 2022
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 3, 2014
SELECTSITE
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code DYB·June 7, 2013
LEAD MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 22, 2011
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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