26 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIVA combo RF System (VIVA combo RF System)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODULAR FLEXIBLE REAMER HEAD, Ø14.0mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000955·
Ophthalmic Spoon
FDA UDI
KATENA PRODUCTS, INC.·00841668103494·KANSAS NUCLEUS LOOP 3MM WIDE
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
FDA 510(k)
FDA Class 2
·Radiology
aprevo® transforaminal lumbar interbody fusion device
FDA 510(k)
FDA Class 2
·Orthopedic
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·May 5, 2021
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·January 21, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 30, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 7, 2014
XENFORM
FDA Adverse Event
Other
·TEI BIOSCIENCES INC.·Product code FTM·July 16, 2013
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 17, 2023
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 20, 2023
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 23, 2024
VNGD SSK PSC TIB BRG 12X63/67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
VNGD POST FEM AUG 65X10 LL/RM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·June 3, 2021
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 15, 2024
CHAMBER COMPLETE AUTOFEED 900
FDA Adverse Event
Malfunction
·Product code BTT·February 4, 2021
BIOMET TIB BLOCK 6MM 67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 5, 2023