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

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Healy

FDA 510(k)
FDA Class 2 ·Neurology

THINFLAP SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036088507·

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105514R1·IN-OVATION® mini Rhodium Base Rx 018 UL/5-5 CS ...

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055241·IN-OVATION® mini Base Rx 022 UL/5-5 CS BC HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523P1·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK PSV

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055131·IN-OVATION® mini Base Rx 018 UL/5-5 CS HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105523R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191055231·IN-OVATION®mini Base Rx 022 UL/5-5 CS HK

IN-OVATION® Mini

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K19105524R1·IN-OVATION®mini Rhodium Base Rx 022 UL/5-5 CS B...

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ELECSYS INSULIN CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PERITONEAL DIALYSIS CYCLER SET

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 20, 2013

UNKNOWN SPINAL CORD STIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 29, 2011

SENSOR ENLITE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 21, 2014

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018