16 results · 22ms · Sources: EU EUDAMED, US FDA

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EM Provisional

FDA 510(k)
FDA Class 2 ·Dental

IN-OVATION® Mini

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

IN-OVATION® Mini

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

BD POSIFLUSH¿ SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·January 31, 2018

BD POSIFLUSH¿ SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 19, 2018

VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR

FDA 510(k)
FDA Class 2 ·Radiology

DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP

FDA 510(k)
FDA Class 2 ·Orthopedic

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 26, 2013

ACCENT DR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

CENTRA 850 BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·July 28, 2011

PANEL PHOENIX NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 4, 2024

PANEL PHOENIX NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 5, 2024

PANEL PHOENIX NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 5, 2024

PANEL PHOENIX NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 5, 2024

PANEL PHOENIX NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 12, 2024

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