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

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VENTRESIGN STREP A TEST

FDA 510(k)
FDA Class 1 ·Microbiology

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756738231·MASTOID PACK

GRIESHABER VISCOELASTIC INJECTION SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

GX-2000 STATIONARY X-RAY GENERATOR

FDA 510(k)
FDA Class 1 ·Radiology

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·January 31, 2024

LIGACLIP CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDO·June 26, 2014

LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·January 4, 2013

TRIGEN

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code HWC·November 11, 2010

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·July 10, 2023

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 10, 2023

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·June 23, 2023

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·June 2, 2023

MASTOID PACK

FDA Adverse Event
Malfunction ·DEROYAL INDUSTRIES, INC.·Product code KDD·June 1, 2015

SYMPHYSPL 3.5 W/COAX-COMBIHO+2 DCP 6HO L

FDA Adverse Event
Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HRS·December 13, 2017

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 17, 2023

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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