15 results · 21ms · Sources: EU EUDAMED, US FDA

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ADHESIVE HYBRID IONOMER CEMENT

FDA 510(k)
FDA Class 2 ·Dental

SINGLE LUMEN CATHETERS, MODIFICATION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

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

PCA PLS II

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·February 19, 2013

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 31, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014

OSS SMOOTH STRAIGHT IM 10MM X 90MM MODULAR STEM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·December 28, 2016

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

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