34 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUCINA MODEL MELODI
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Carbide burs
FDA UDI
DFS - DIAMON GmbH·04057176150356·Carbide 2 CA 1,6 mm
Lupus Anticoagulant Confirmation Reagent
FDA UDI
Bio/Data Corporation·G0561025161·
Bio-logic
FDA UDI
NATUS MEDICAL INCORPORATED·00382830052177·Disposable Subdermal Needle Electrode 1M
ALL SILICONE FOLEY BALLOON CATHETER
FDA UDI
Sewoon Medical Co., Ltd.·08806369400527·2way/Green 30cc 16fr
Zavation
FDA UDI
Zavation LLC·00842166196612·Whitney TLIF 25, 6deg 16mm
Forefoot Screws
FDA UDI
Life Spine, Inc.·00190837019945·
EBI SPINELINK - II SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANYPLUS PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 2, 2024
LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 9, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 19, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·May 20, 2011
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023
COMPR NANO HMRL PPS 34MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024
BD NANO¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 4, 2019
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 7, 2022
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 11, 2020
PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 13, 2020
COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024