11 results
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19ms
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Sources: EU EUDAMED, US FDA
VITAL Tubing Sets for Hemodialysis
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918185385·Baby blanket_printing_75cmx100cm_Non-sterilze_1...
SMARTEZ
FDA Adverse Event
Malfunction
·EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED·Product code MEB·May 5, 2026
SMARTEZ PUMP
FDA Adverse Event
Malfunction
·EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED·Product code MEB·May 5, 2026
Turbo High-Flow Non-coring Needle
FDA 510(k)
FDA Class 2
·General Hospital
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059
FDA 510(k)
FDA Class 2
·Dental
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 22, 2023
UNKNOWN TALAR COMPONTENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSN·November 14, 2014
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·September 13, 2011
1.85MM TI MATRIX SCREW SELF-DRILLING/5MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·July 29, 2013
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020