7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TEE ADAPTER
FDA 510(k)
FDA Class 1
·Anesthesiology
ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
Leksell Vantage Stereotactic System
FDA 510(k)
FDA Class 2
·Neurology
MITEK EXPRESSEW III NEEDLE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·May 5, 2014
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·October 15, 2012
ISOLINE
FDA Adverse Event
Injury
·SORIN BIOMEDICA CRM·Product code MRM·August 5, 2010
Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017