12 results · 26ms · Sources: EU EUDAMED, US FDA

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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