26 results · 42ms · Sources: EU EUDAMED, US FDA

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DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ZenFlex

FDA UDI
Kerr Corporation·00195062029776·Rotary Files

N/A

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551921·In-Ovation R RNC/BASE/EURO 018 UL5-5 CS-BC HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK

IN-OVATION® R

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183U1·IN-OVATION® R EURO 018 U5-5 CS-1BC HK

IN-OVATION® R

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183L1·IN-OVATION® R EURO 018 L5-5 CS-1BC HK

IN-OVATION® R

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551821·IN-OVATION® R EURO 018 UL/5-5 CS-BC HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK

PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M

FDA 510(k)
FDA Class 1 ·Dental

TWIN NEUROTRAC-III

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

ATLAS II PLUS DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·June 4, 2019

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023

IMPEDE-FX EMBOLIZATION PLUG

FDA Adverse Event
Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021