205 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLARIS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450585108·
IVENT 201 PORTABLE VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
M4 MONITOR
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
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·June 2, 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 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
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code MPN·December 10, 2018
HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML
FDA Adverse Event
Malfunction
·B BRAUN SURGICAL SA·Product code MPN·February 7, 2019
HISTOACRYL BLUE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·January 29, 2019