19 results
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21ms
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Sources: EU EUDAMED, US FDA
STERILIZING CASE CAT. NO. 65199
FDA 510(k)
FDA Class 2
·General Hospital
FUSION Curing Light
FDA UDI
Dentlight Inc.·00860179001006·FUSION Curing Light
NovaPort cannula
FDA UDI
novalung GmbH·04260058550759·The NovaPort® one cannulas are thin-walled, wir...
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000800·3SUR4.25-1-3P | 3P 14 User Triple Surgical Vacu...
Geniant Cranial
FDA UDI
KOH YOUNG TECHNOLOGY INC.·08800050902062·80 mm Fixation Pin
Portex
FDA UDI
ICU MEDICAL, INC.·15019517076936·
SUPERION INDIRECT DECOMPRESSION SYSTEM
FDA Adverse Event
Injury
·VERTIFLEX INC.·Product code NQO·April 10, 2020
ASNIS III CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLIDE WHITE APEX SUPERIOR ADHESIVE
FDA Adverse Event
Injury
·Product code KEW·January 28, 2022
Instrument Case
FDA UDI
Zimmer, Inc.·00889024064775·
PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·February 1, 2019
SLIDE WHITE APEX SUPERIOR ADHESIVE
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS·Product code KES·July 16, 2024
TRACHEOSTOMY PVC - PORTEX TUBES BLUE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·October 13, 2022
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·April 28, 2023
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·October 22, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014
PULSE GEN MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 11, 2010
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025