25 results · 25ms · Sources: EU EUDAMED, US FDA

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EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

REMEL

FDA UDI
REMEL, INC.·00848838006784·CTA w/1% Sucrose (4ml) 20/PK

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70606601·Sprint II Brackets Roth .022" 1000 Brackets 3 w...

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0606000·Tray, Base, 6"

8015 ALARIS SYSTEM PC UNIT

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·June 29, 2021

8015 ALARIS SYSTEM PC UNIT

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·June 29, 2021

8015 ALARIS SYSTEM PC UNIT

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·June 29, 2021

8015 ALARIS SYSTEM PC UNIT

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·June 29, 2021

HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO

FDA 510(k)
FDA Class 2 ·General Hospital

ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413

FDA 510(k)
FDA Class 2 ·Cardiovascular

Widex

FDA UDI
Widex A/S·05706069898262·WIDEX EVOKE E-CIC-M TR (Light beige ) 50

Widex

FDA UDI
Widex A/S·05706069898286·WIDEX EVOKE E-CIC-M TR (Dark brown ) 50

Widex

FDA UDI
Widex A/S·05706069898279·WIDEX EVOKE E-CIC-M TR (Clay brown ) 50

ASR ACETABULAR CUPS 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013

HENRY SCHEIN ONE STEP+ HCG URINE STRIP TEST

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·April 8, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 13, 2008

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·March 29, 2023

ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 30, 2023

ECHELON ENDOPATH STAPLER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 5, 2023

BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

FDA Enforcement
Class II ·Ongoing·Becton, Dickinson and Company, BD Biosciences·November 9, 2022