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

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Cortex CAD/CAM Abutments

FDA 510(k)
FDA Class 2 ·Dental

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780463337·Castroviejo Corneoscleral Scissors 4-1/2", Left...

BEAMER ARGON SNARE PROBE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NEV'S INK AUTOCLAVE TAPES

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

4K CAMERA HEAD

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FET·September 18, 2023

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·June 21, 2013

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·July 5, 2011

ACCU-CHEK CONFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 25, 2008

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 15, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 11, 2017

G8

FDA Adverse Event
Malfunction ·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025

BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·January 13, 2016