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