13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COUGHASSIST T70 DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code KWT·October 6, 2022
SYNCRA CRT-P
FDA Adverse Event
Death
·IPG MFG SWITZERLAND·Product code NVZ·May 21, 2013
QUIKDRIVE BATTERY POWERED SCREWDRIVER MINI
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·May 23, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·August 13, 2008
BD ULTRA-FINE MINI PEN NEEDLES 5MM (3/16) 31G
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·July 1, 2020
ENDURO MENISCAL COMPONENT F1 10MM
FDA Adverse Event
Injury
·AESCULAP IMPLANT SYSTEMS·Product code KRO·October 11, 2016
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
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 Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023