11 results
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21ms
·
Sources: EU EUDAMED, US FDA
THE HUMPHREY FIELD ANALYZER MODEL 610
FDA 510(k)
FDA Class 1
·Ophthalmic
LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OREIA II, B-HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·September 28, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 5, 2015
M2A 1 PC SHELL 38MMX56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 26, 2016
M2A 1 PC SHELL 38MMX54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 26, 2016
M2A 38MM MOD HD+6MM NK NO SKRT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·August 26, 2016
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012