13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLIM E30 II CO2 LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMIT 2000 GENTAMICIN PLUS ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
XYLOS VESSEL GUARD
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
BD INTIMA II¿ IV CATHETER PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·March 9, 2023
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
BD INTIMA II¿ IV CATHETER PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·September 19, 2022
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 9, 2013
MAXILIFT
FDA Adverse Event
Malfunction
·ARJO MED AB LTD.·Product code FSA·April 1, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 4, 2025
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025