19 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QBTES
FDA 510(k)
FDA Unclassified
·Unknown
Z Liquid HT B3-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818122149·Dental porcelain/ceramic restoration kit
GAUNYING INFRARED LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2015
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 21, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. TAIWAN·Product code INI·September 26, 2014
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·June 13, 2011
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018
SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024