12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EASYCARE TX SYSTEM (CONNEXUNS)
FDA 510(k)
FDA Class 2
·Anesthesiology
Mask DSPS®-PROSCVR set/5
FDA UDI
MACROMEDICS B.V.·08720168162878·Mask DSPS®-PROSCVR set/5
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837043490·Aileron Implant Caddy
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105247·PS3 Screw 7.5mm x 80mm
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
FDA 510(k)
FDA Class 2
·Cardiovascular
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDS·July 22, 2022
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR CORPORATION·Product code OBR·May 1, 2014
DVR ANATOMIC STANDARD RIGHT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HRS·May 15, 2013
DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·June 2, 2011
DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
FDA 510(k)
FDA Class 2
·Radiology
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025