13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CD Horizon Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
STRAIGHT FIRE HOLMIUM LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LC4200 PCA PLUS AUST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 8, 2012
LC4200 PCA AUST
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·October 20, 2010
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 13, 2012
LC4200 PCA PLUS AUST
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code MEA·March 1, 2012
PCA PUMP (AUZ)
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·June 2, 2010
CATHETER
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code BSO·February 22, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 9, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·July 2, 2014
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 4, 2020
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024