15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
FDA 510(k)
FDA Class 2
·Orthopedic
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869213010·burr cleaning brushes, designed for cleaning bu...
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008992·Votion .022 R UR3 -2T 13A 4MO (10PK)
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010827·Pinnacle .022 R UR3 -2T 13A 4MO (10PK)
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114695·Votion .022 R UR3 -2T 13A 4MO (10PK) VOTION
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112769·Pinnacle .022 R UR3 -2T 13A 4MO (10PK) PINNACLE
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
XPRESSWAY RX CATHETER (6F LD-VERISON)
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDP·August 26, 2019
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·May 21, 2014
INTELLIVUE INFORMATION CENTER CLIENT
FDA Adverse Event
Death
·PHILIPS HEALTHCARE·Product code MHX·December 6, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 17, 2013
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026