23 results · 24ms · Sources: EU EUDAMED, 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