10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Axon Therapy
FDA 510(k)
FDA Class 2
·Neurology
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CHAD THERAPEUTICS SAGE
FDA 510(k)
FDA Class 2
·Anesthesiology
L.TAMPONSORGCOTTONCOMPAKREGNORNONDO45CT
FDA Adverse Event
Injury
·ONTEX HYGIENEARTIKEL GMBH·Product code HEB·August 5, 2021
INTIMA-II Y 24GAX0.75IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·January 13, 2021
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 19, 2008
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·September 2, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
FDA Adverse Event
Malfunction
·AOMORI OLYMPUS CO., LTD.·Product code GEI·November 10, 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