9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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pNOVUS 21 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Patient Positioning Devices
FDA 510(k)
FDA Class 2
·Radiology
Infrared Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
PRESSUREWIRE X, WIRELESS, RX 175CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DQX·August 6, 2020
PREMIUM SURGICLIP* S-9.0 TITANIUM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code FZP·November 11, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
EVOLIS CEMENTED TIBIAL BASE PLATE SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·July 17, 2013
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