23 results · 24ms · Sources: EU EUDAMED, US FDA

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Symphion Operative Hysteroscopy System

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED

LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU

FDA 510(k)
FDA Class 2 ·Anesthesiology

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 18, 2009

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·May 17, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·December 18, 2009

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·November 17, 2009

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

ACCESS

FDA Adverse Event
Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·September 2, 2011

ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·July 18, 2013

MAQUET HCU30 DEVICE

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWC·November 18, 2015

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·May 25, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·May 31, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·May 31, 2010

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 7, 2011

MENTOR SMOOTH ROUND SPECTRUM

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·November 28, 2018

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·June 23, 2011