9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AD-TECH'S SPINAL ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
FINGERTIP PULSE OXIMETER, MODEL CMS-50C
FDA 510(k)
FDA Class 2
·Cardiovascular
Multi-parameter Patient Monitor, models C30
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR SILTEX ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 14, 2019
TRI-LOCK BPS SZ 4 HI OFFSET
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·February 22, 2013
MULTIRATE INFUSOR LV 2,4,6 12PACK FOR JAPAN ONLY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·January 30, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 1, 2014
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025