204 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAUTILUS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SMDIA-1000
FDA 510(k)
FDA Class 2
·Anesthesiology
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
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 14, 2013
LIGASURE V
FDA Adverse Event
Malfunction
·COVIDIEN VALLEYLAB·Product code GEI·May 29, 2011
SMALL JOINT AGGRESSIVE PLUS CUTTER
FDA Adverse Event
Malfunction
·STRYKER PUERTO RICO·Product code HRX·August 11, 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
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 18, 2025
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, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; 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