101 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Audit MicroControls Control FD Assayed Chemistry, Level 2
FDA UDI
AALTO SCIENTIFIC·B085K0312100·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036024284·
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
FDA 510(k)
FDA Class 2
·Orthopedic
CORRECT PLUS
FDA 510(k)
FDA Class 2
·Dental
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 30, 2022
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 2, 2013
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 22, 2011
BD INSULIN SYRINGE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMF·April 14, 2008
Nerve Block Tray Catalog Number: 6796R3
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
MONOPLUS VIOLET 0 (3,5) 90CM HR37S(M)RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.U.·Product code NEW·December 14, 2021
MONOPLUS C VIOLET 2/0 (3) 25M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code NEW·January 2, 2019
MONOPLUS VIOLET 4/0 (1.5) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code NEW·October 23, 2019
MONOPLUS C VIOLET 2/0 (3) 25M
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code NEW·June 2, 2022
MONOPLUS VIOLET 3/0 (2) 70CM HR22 (M)RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code NEW·July 30, 2021
MONOMEND MAX 2/0 (3)70CM HS37S(M)VPL DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code NEW·August 13, 2021
MONOPLUS VIOLET 4/0(1,5)4X45 HR22 TO(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code NEW·October 2, 2019
MONOMEND MAX 3/0 (2) 70CM DS24(M)VPL RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code NEW·July 31, 2023
MONOPLUS C VIOLET 2/0 (3) 25M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code NEW·January 30, 2019
MONOMEND MAX 2/0 27" (70CM)HR26S VPL RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code NEW·November 7, 2022