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

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DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

FDA 510(k)
FDA Class 2 ·Immunology

DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls

FDA 510(k)
FDA Class 2 ·Immunology

SYSTEM 98XT, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·February 3, 2026

SYSTEM 98XT

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 22, 2025

ASSY,ENGLISH,DOMSTC,110V,SYS98

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·December 26, 2025

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·November 3, 2025

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

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

ULTRAMAX

FDA Adverse Event
Injury ·ATRIUM MEDICAL CORP.·Product code DSY·January 2, 2013

COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

FDA Adverse Event
Malfunction ·STAAR SURGICAL CO.·Product code HQL·January 12, 2011

GYNECARE TVT RETROPUBIC SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 29, 2014

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

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

ASSY,ENGLISH,DOMSTC,110V,SYS98

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 15, 2025

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·February 6, 2017

SENSATION 7FR. 34CC IAB

FDA Adverse Event
Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021