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

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Gem FlowCoupler System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK

In-Ovation ® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191252811·IN-OVATION® mini EURO 022/UL5 -7T 0A HK

IMPLANT CENTER 2

FDA 510(k)
FDA Class 2 ·Dental

NEOTRACT ANCHOR SYSTEM MODEL: REF 11208

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

980 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

840 VENTILATOR

FDA Adverse Event
Injury ·COVIDIEN·Product code CBK·June 20, 2017

840 VENTILATOR

FDA Adverse Event
Injury ·COVIDIEN·Product code CBK·August 1, 2017

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·July 25, 2017

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·August 17, 2017

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·March 21, 2017

6600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 19, 2011

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·June 26, 2013

SILICONE ADVANCED OPTIC-VIOLET SHIELD

FDA Adverse Event
Malfunction ·BAUSCH & LOMB·Product code HQL·September 26, 2008

840 VENTILATOR

FDA Adverse Event
Injury ·COVIDIEN·Product code CBK·June 26, 2017

dS Breast 16ch 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024