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

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LED Curing Light

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120571·Guidewire 2.0x150mm Sgl Trocar

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120564·Guidewire 2.0x150mm Dbl Trocar

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199564·Modular Knee Straight Reamer - 20mm

BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

FRONTIER DEVICES NEURO SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

ADVANTAGE FIT BLUE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 24, 2025

SOLYX BLUE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PAH·March 6, 2025

SOLYX BLUE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PAH·January 13, 2026

SOLYX BLUE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PAH·January 7, 2026

ADVANTAGE FIT ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

ADVANTAGE FIT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 11, 2024

SOLYX BLUE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code PAH·November 14, 2025

BIB INTRAGASTRIC BALLOON SYSTEM

FDA Adverse Event
Malfunction ·APOLLO ENDOSURGERY·Product code LTI·June 27, 2024

OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM

FDA Adverse Event
Malfunction ·APOLLO ENDOSURGERY·Product code OCW·August 28, 2025

LYNX ULTRA SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PCU·April 23, 2024

PERCUFLEX URINARY DIVERSION STENT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LJE·May 15, 2025

OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OCW·March 20, 2026