15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
FDA 510(k)
FDA Class 2
·Immunology
Custom Canal Finder Reamer
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215139377·
DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
FDA 510(k)
FDA Class 2
·General Hospital
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
COULTER AC.T DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·October 10, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 15, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·June 11, 2013
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
SENSATION 7FR. 34CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021