332 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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Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185541·AccuFit™ Molar Band UR7 - 37.5
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113119·HALO, 1203-5 VEST XX-LARGE, ACRYLIC LINER, 1211...
Proximal Humeral Plate
FDA UDI
I.T.S. GmbH·09120069813609·Proximal Humeral Plate, AP Flange, Large, 5-Hole
STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 22, 2008
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 8, 2011
GYNECARE X-TRACT MOTOR DRIVE UNIT
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 8, 2013
PREMILENE/MONOSYN SET
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL S.A.·Product code GAW·August 7, 2015
MONOSYN UNDYED 5/0 (1)45CM DSMP11(M).RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·November 11, 2021
MONOSYN VIOLET 6/0 (0,7)45CM DS12(M).RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 29, 2026
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·June 1, 2023
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 3, 2023
MONOSYN UNDYED 4/0 (1.5) 45CM HSMP15 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·August 7, 2019
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Death
·INSULET CORPORATION·Product code LZG·July 19, 2023
MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 24, 2019
MONOSYN VIOLET 0 (3.5) 70CM HR40S (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·February 12, 2020
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
MONOSYN UNDYED 5/0 (1) 70CM DS12 (M).RCP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·September 17, 2019