16 results
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24ms
·
Sources: EU EUDAMED, US FDA
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984166·anteriors; shade A3.5; mould 91
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123007·K-WIRE - SINGLE TROCAR 1.6mm DIA x 150mm
DICOR CERAMIC INLAY - NEW TECHNIC
FDA 510(k)
FDA Class 2
·Dental
THERMOSURGERY TM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·December 13, 2013
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·January 8, 2014
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 12, 2015
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·September 6, 2012
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 24, 2013
BIA400 IMPLANT 4MM W ABUTMENT 8MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·May 25, 2016
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·April 1, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·February 28, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 10, 2011
PERFORATOR DRIVER W/HUDSON END
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLSTHE ANSPACH EFFORT, INC.·Product code HBE·December 18, 2013
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