8 results
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25ms
·
Sources: EU EUDAMED, US FDA
KDG ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
discovery®
FDA UDI
DENTAURUM GmbH & Co.KG·J011891262000·10 cases discovery® Hilgers 18 Brackets / For ...
aBSI
FDA 510(k)
FDA Class 2
·Radiology
MR CARDIAC FUNCTION ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 24, 2014
INTRALASE IFS LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC.·Product code HNO·October 27, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS·Product code MKJ·November 27, 2012
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012