11 results · 18ms · Sources: EU EUDAMED, US FDA

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HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)

FDA 510(k)
FDA Class 2 ·Hematology

LifeFlow Blood System

FDA 510(k)
FDA Class 2 ·General Hospital

CERAMIC PEDATRIC PREFORMED CROWN

FDA 510(k)
FDA Class 1 ·Dental

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006

ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEO·June 19, 2006

METRX

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·March 6, 2013

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014

AFFINITY BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code HDD·January 27, 2011

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021