12 results
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26ms
·
Sources: EU EUDAMED, US FDA
BIOTROL BILIRUBIN C & T CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EQUISTREAM Long-Term Hemodialysis Catheter
FDA UDI
Bard Access Systems, Inc.·00801741013812·EQUISTREAM HEMODIALYSIS CATH, ALPHACURVE, AIRGU...
Drill Extender
FDA UDI
STERNGOLD DENTAL LLC·00841549118067·Tool to be added to implant instrument to incre...
CENTRIPREP 100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DISPOSIBLE EEG NEEDLE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
ALTRX +4 NEUT 40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 18, 2010
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·September 4, 2019
1.5 X 6 MM HIGH TORQUE SELF-DRILLING CROSS-DRIVE SCREW EACH
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·October 20, 2016
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017