217 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Milli Vaginal Dilator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVIS EXERA III VIDEO SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 29, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·August 15, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2013
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