14 results
·
29ms
·
Sources: EU EUDAMED, US FDA
BIO-CHEM ANALYZER, MODEL 100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074037264·BONE SCREW 7040750 ILIAC 7.5X50 TI
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496040750·WENDY MAXI, SIZE M, MOKA, MICRO-MASSAGING LEGGI...
Cortera
FDA UDI
Xtant Medical Holdings, Inc.·00840311210527·Tap, Cann, Jacobs, 7.5
NA
FDA UDI
Summit Medical, Inc.·00385640001175·
RHIGENE MESACUP2 TEST- SCL-70
FDA 510(k)
FDA Class 2
·Immunology
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
FDA 510(k)
FDA Class 2
·Hematology
SERIES A PAT W/WR THN 28 1 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 12, 2022
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 5, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 5, 2017
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·April 8, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·May 9, 2008
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018