13 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMART-READ EZTEST-STEAM SCBI AND TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450595145·
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
FDA 510(k)
FDA Class 1
·General Hospital
ELISA TEST, SEROLOGY
FDA 510(k)
FDA Class 1
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 22, 2024
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 21, 2015
NEXIVA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 3, 2026
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·February 19, 2015
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 6, 2013
COMPRESS FACE REAMER LARGE
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HTO·September 16, 2014
AXSYM HBSAG
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code KSJ·May 18, 2011
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