18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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