217 results · 32ms · Sources: EU EUDAMED, 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