217 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ClearView cCAD
FDA 510(k)
FDA Class 2
·Radiology
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310
FDA 510(k)
FDA Class 2
·Cardiovascular
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·November 22, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 6, 2019
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code JDI·October 10, 2014
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 3, 2013
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code LZS·March 29, 2011
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·June 27, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·October 17, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·April 18, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·April 18, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·April 18, 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
HISTOACRYL BLUE TISSUE ADHESIVE
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code MPN·January 23, 2020
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·September 23, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·March 8, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·August 6, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·September 3, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code MPN·December 10, 2018