24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BCI 3403 SLEEP SCREENING PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964153297·Endo Carry-on Procedure Kit contains Basin, Via...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014271·Zirlux 16+ C2 98.5X22
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLEEP PAT 200 DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
9616240-2006-00341
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
9616240-2006-00332
FDA Adverse Event
Other
·Product code FII·June 1, 2006
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
9616240-2006-00339
FDA Adverse Event
Malfunction
·Product code FII·June 9, 2006
9616240-2006-00340
FDA Adverse Event
Malfunction
·Product code FII·June 9, 2006
9616240-2006-00350
FDA Adverse Event
Malfunction
·Product code FII·June 23, 2006
9616240-2006-00345
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
PHOENIX
FDA Adverse Event
Malfunction
·GAMBRO DASCO·Product code FII·May 10, 2006
STRATTICE
FDA Adverse Event
Injury
·LIFECELL·Product code FTM·May 26, 2011
OPTI-FREE PUREMOIST MPDS
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·March 15, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 8, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023