14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
FDA 510(k)
FDA Class 2
·Ophthalmic
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104776·PS3 Screw 4.5mm x 50mm
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOWRIST ONE SUCTION/IRRIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 25, 2021
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 15, 2013
CAPSURE SP
FDA Adverse Event
Death
·MPRI·Product code DTB·September 24, 2014
GEMSTAR 7 THERAPY I
FDA Adverse Event
Injury
·HOSPIRA, INC.·Product code FRN·May 31, 2011
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·July 17, 2014
BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 4, 2023
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025