9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
FDA 510(k)
FDA Class 2
·Orthopedic
AAXTER A3 POSTERIOR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 30, 2013
PROPAQ CS 246
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code DRT·June 8, 2011
COZMONITOR GLUCOSE MONITOR
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code NBW·September 4, 2008
10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 3, 2019
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016