28 results · 20ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO: SECTRA IDS5 WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

PYRAMESH® Implant System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484497·MESH 9051315 PYRM IMPLANT 13MMX15MM RND

PYRAMESH® Implant System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855666·MESH 9051315 PYRM IMPLANT 13MMX15MM RND

DETACHOL

FDA UDI
FERNDALE LABORATORIES, INC.·00304960513151·ADHESIVE REMOVER

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475704·

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475728·

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475759·

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475735·

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475766·

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475773·

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475742·

FIX-C PEEK ACIF SA System

FDA UDI
Jeil Medical Corporation·08800089475711·

MODIFICATION TO KION ANESTHESIA SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5

FDA 510(k)
FDA Class 2 ·Radiology

EXPECT PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·May 19, 2026

EXPECT PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 24, 2025

ACQUIRE? PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·October 10, 2025

EXPECT PULMONARY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·November 14, 2024

CELL-DYN DILUENT/SHEATH

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

EXPECT PULMONARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCG·April 14, 2026