22 results · 23ms · Sources: EU EUDAMED, US FDA

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SMR Reverse Liner

FDA 510(k)
FDA Class 2 ·Orthopedic

TIXOS IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 18, 2026

TRANSFX EXTERNAL FIXATION SYSTEM DRILL BIT QUICK-CONNECT

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HTW·October 31, 2008

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 23, 2011

UNKNOWN DEPUY ACETABULAR LINER

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 11, 2013

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis·Product code OWB·March 3, 2026

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·January 13, 2025

BIOABSORBABLE INTERFERENCE SCREWS

FDA Adverse Event
Malfunction ·S.B.M. SAS·Product code MAI·August 22, 2024

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026