12 results · 21ms · Sources: EU EUDAMED, US FDA

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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