7 results
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18ms
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Sources: EU EUDAMED, US FDA
MULTIANALYTE CONTROLS-ALL KINDS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BEGOPAL+
FDA 510(k)
FDA Class 2
·Dental
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
FDA 510(k)
FDA Class 2
·Radiology
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 21, 2014
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code LRK·October 29, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 2, 2010
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