95 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMASORB APPLY
FDA 510(k)
FDA Unclassified
·Unknown
ArgenZ HT+ 98x16 B2
FDA UDI
ARGEN CORPORATION, THE·D818121953·Dental porcelain/ceramic restoration kit
MITEK PDS/PGA STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
SMDIA-1000
FDA 510(k)
FDA Class 2
·Anesthesiology
CELLEX PHOTOPHERESIS MACHINE AND DISPOSABLE SET
FDA Adverse Event
Malfunction
·THERAKOS·Product code LNR·May 15, 2013
TRIMA ACCEL PLT, PLS, RBC SET
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·June 1, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·August 13, 2008
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 11, 2019
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 11, 2019
PEN NDL 31GA 8MM 100 BX 1200 USA
FDA Adverse Event
Injury
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·December 12, 2024
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 29, 2019
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 31, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 17, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 3, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 4, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 13, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 4, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 6, 2019
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 11, 2019