8 results
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17ms
·
Sources: EU EUDAMED, US FDA
REFLOTRON URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642698·OPAQUE MATERNITY 20-30 MM HG THIGH HIGH ZIG ZAG...
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDCHANNEL HTS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·December 7, 2012
VANGUARD CR TIBIAL BEARING 12X71/75
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 23, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012