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UPDATE OPTICAL MANUFACTURER LIMITED

FDA registration
UPDATE OPTICAL MANUFACTURER LIMITED·3 products·🇨🇳 China

IMPELLA CP

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·September 30, 2024

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 23, 2025

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·May 27, 2025

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·January 1, 2026

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·April 17, 2025

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·January 12, 2026

IMPELLA 5.5

FDA Adverse Event
Death ·ABIOMED, INC.·Product code OZD·August 6, 2025

SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·March 19, 2026

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 14, 2025

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·June 17, 2025

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·December 20, 2024

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·April 1, 2025

SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·December 2, 2025

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·August 25, 2025

TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·January 14, 2026

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·January 5, 2026

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·December 28, 2025

7MM EXTENDED LENGTH ENDOSCOPE

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GCJ·September 2, 2025

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·June 18, 2025