13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SI-Restore Sacroiliac Joint Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
EON MINI 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 8, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES(USA)·Product code HRS·May 15, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES(USA)·Product code HWC·May 8, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES(USA)·Product code HWC·May 15, 2014
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES(USA)·Product code HRS·May 8, 2014
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Enforcement
Class II
·Completed·Mako Surgical Corporation·November 25, 2020
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024