15 results · 19ms · Sources: EU EUDAMED, 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