7,099 results · 39ms · Sources: EU EUDAMED, US FDA

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GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code MAF·November 6, 2018

XPERT BCR-ABL ULTRA

FDA Adverse Event
Malfunction ·CEPHEID·Product code OYX·June 10, 2025

XPERT BCR-ABL ULTRA

FDA Adverse Event
Malfunction ·CEPHEID·Product code OYX·December 17, 2024

XPERT BCR-ABL ULTRA

FDA Adverse Event
Malfunction ·CEPHEID·Product code OYX·June 9, 2025

XPERT BCR-ABL ULTRA

FDA Adverse Event
Malfunction ·CEPHEID·Product code OYX·April 23, 2025

XPERT BCR-ABL ULTRA

FDA Adverse Event
Malfunction ·CEPHEID·Product code OYX·March 10, 2025

XPERT BCR-ABL ULTRA

FDA Adverse Event
Malfunction ·CEPHEID·Product code OYX·March 30, 2026

Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

FDA Recall
Open, Classified ·Cepheid·Product code OYX·October 30, 2025

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

FDA Recall
Open, Classified ·Bio-Rad Laboratories·Product code OYX·February 15, 2024

Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

FDA Recall
Open, Classified ·Cepheid·Product code OYX·October 30, 2025

Bcr/Abl1 Monitoring Test

FDA classification
FDA Class 2 ·Bcr/Abl1 Monitoring Test

BIOHIT OYJ

FDA registration
BIOHIT OYJ·1 product·🇫🇮 Finland

ONYX MEDICAL LLC

FDA registration
ONYX MEDICAL LLC·68 products·🇺🇸 United States

ONYX INDUSTRIES, INC.

FDA registration
ONYX INDUSTRIES, INC.·4 products·🇺🇸 United States

ONYX HEALTHCARE INC.

FDA registration
ONYX HEALTHCARE INC.·2 products·🇹🇼 Taiwan

OnX Tough

FDA 510(k)
FDA Class 2 ·Dental

ONYX HEALTHCARE USA, INC.

FDA registration
ONYX HEALTHCARE USA, INC.·5 products·🇺🇸 United States

Vera Wang

FDA UDI
Kenmark Optical, Inc.·00715317037662·Nyx Tortoise Spectacle

Vera Wang

FDA UDI
Kenmark Optical, Inc.·00715317037655·Nyx Demi Horn Spectacle

Vera Wang

FDA UDI
Kenmark Optical, Inc.·00715317037648·Nyx Burgundy Spectacle