25 results
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22ms
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Sources: EU EUDAMED, US FDA
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Coseal Surgical Sealant
FDA UDI
BAXTER HEALTHCARE CORPORATION·05413765404634·Coseal Surgical Sealant (Coseal) is composed of...
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 17, 2024
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code NBE·December 6, 2023
INSTRUMENT, DENTAL
FDA 510(k)
FDA Class 1
·Dental
CONTINUUM KNEE SYSTEM (CKS)
FDA 510(k)
FDA Class 2
·Orthopedic
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 23, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·June 5, 2023
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 2, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 30, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 1, 2014
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·June 16, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·March 15, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH¿·Product code HRX·May 5, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 11, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 25, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 11, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 24, 2023
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp·June 8, 2016
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 18, 2023