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

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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