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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OLYMPUS
FDA UDI
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED·15019778003191·
OLYMPUS
FDA UDI
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED·15019778003238·
ORCA Foam Powder
FDA UDI
Orca Products, LLC·00850056665247·"AbsorbaleGelatin Powder--Pre-filled 1g Syringe
"
ORCA Foam Powder
FDA UDI
Orca Products, LLC·00850056665292·AbsorbaleGelatin Powder--Pre-filled 550mg Syringe
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITEK® 2 GN ID TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code JTO·January 18, 2017
VITEK® 2 GN ID TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code JTO·January 20, 2017
VITEK® 2 GN ID CARD
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code JTO·December 28, 2016
VITEK® 2 GN TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code JTO·December 30, 2016
ACCOLADE DR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWP·October 28, 2022
BIMOBILE DUAL MOBILITY SYSTEM
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code MEH·July 18, 2025
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEQ·August 23, 2024
MAJ-2207 IRRIGATION TUBING CO2 PK10
FDA Adverse Event
Injury
·KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD·Product code OCX·September 7, 2022
FLUSHING PUMP OFP-2 (US)
FDA Adverse Event
Injury
·KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD·Product code FEQ·September 7, 2022
ENDO MODEL
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·February 18, 2025
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·December 10, 2014
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JWH·March 19, 2021
Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.
FDA Recall
Terminated
·Olympus America Inc.·Product code FEQ·December 12, 2011
ISOFLEX OPTIM LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVY·November 18, 2021