12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
FDA 510(k)
FDA Class 2
·Anesthesiology
STELKAST UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 20, 2022
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 12, 2022
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 2011
OCEAN WATER SEAL CHEST DRAIN
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP·Product code KDQ·August 21, 2008
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 18, 2015
HLM TUBING SET W/SOFTLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 3, 2016
HLM TUBING SET W/BIOLINE COATING
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 2, 2016