217 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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HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
FDA 510(k)
FDA Class 2
·General Hospital
AccuQuest
FDA UDI
Bernafon AG·05711584079232·AQ CO9 MNR, 2.4G NFM PB COBR ACCUQ
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
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·July 28, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 21, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 26, 2008
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
BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 17, 2015
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