12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ADVANTAGE TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
GII PS HI FLEX ISRT SZ 7-8 9
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·July 19, 2017
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)
FDA 510(k)
FDA Class 2
·Anesthesiology
syngo VSim
FDA 510(k)
FDA Class 2
·Radiology
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·February 9, 2013
TPE SET, SPECTRA
FDA Adverse Event
Injury
·CARIDIANBCT·Product code LKN·December 29, 2010
ECHELON LINEAR CUTTER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 23, 2014
CRTS RA VLV ONLY
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·October 10, 2023
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015