8 results
·
32ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471166035·SAGITTAL BLADE - DE SOUTTER PRISMATIC 25 x 100 ...
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TERUMO STERNAL SAW II
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·May 19, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 10, 2010
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