23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JOURNEY BCS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange
PERCUFIX
FDA UDI
Stryker GmbH·03700586904910·Depth Gauge
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258660660·
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELECSYS ANTI-TPO CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
1049092-2018-00287
FDA Adverse Event
Injury
·Product code FRO·May 15, 2018
9618003-2021-01239
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021
ADULT INSPIRATORY-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·May 20, 2010
MIC-KEY LOW PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE
FDA Adverse Event
Death
·KIMBERLY-CLARK HEALTH CARE·Product code KNT·May 3, 2013
OTHER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDS·September 16, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 11, 2011
Dressing, wound, drug
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·September 9, 2021
BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·March 24, 2011
COOK CELECT FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·October 18, 2017
COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·September 22, 2016
COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·June 23, 2016
9618003-2021-01006
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 28, 2021
9618003-2021-01210
FDA Adverse Event
Injury
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021