14 results
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20ms
·
Sources: EU EUDAMED, US FDA
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ERA® Implant Abutment Driver Latch Style
FDA UDI
STERNGOLD DENTAL LLC·00841549117831·Used to drive ERA Implant Abutments.
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746063718·DB BKT MINI MS LR CUSP 018 T=0 A+5 R=0
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100963·DB BRACKET MASTER SERIES MAND RIGHT CUSPID 018 ...
Pyramesh® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080666·MESH 905-139 PYRM 13MM X 9MM ROUND
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855352·MESH 905-139 PYRM 13MM X 9MM ROUND
HEMAGEN ENA [JO-I] KIT
FDA 510(k)
FDA Class 2
·Immunology
BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)
FDA 510(k)
FDA Class 2
·Radiology
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DXO·November 22, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2014
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
FDA Enforcement
Class II
·Ongoing·Acclarent, Inc.·December 29, 2021
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024