10 results · 20ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Radiology

VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Revital-Ox RESERT Solution Test Strip

FDA 510(k)
FDA Class 2 ·General Hospital

IMP,TSV,4.1MM,SBM,10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 2, 2022

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 8, 2024

HEADLESS PIN EXTRACTOR

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·November 11, 2014

LCS COMP RP INSERT STD 10MM

FDA Adverse Event
Injury ·DEPUY WARSAW·Product code NJL·September 12, 2011

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 23, 2013

IMP,TSV,4.1MM,SBM,10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 18, 2022

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

FDA Enforcement
Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014