12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ELECSYS HCG ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
FDA 510(k)
FDA Class 2
·Neurology
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
FDA 510(k)
FDA Class 2
·Anesthesiology
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·February 14, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 28, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·January 10, 2011
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·July 21, 2014
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·May 20, 2014
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·April 30, 2014
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·April 9, 2014
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·March 24, 2014
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024