24 results · 38ms · Sources: EU EUDAMED, US FDA

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OASIS MRI System

FDA 510(k)
FDA Class 2 ·Radiology

Luna

FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003430·Luna Opal R Mini .018 Kit 5x5 U

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551113362·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...

BLACKHAWK Cervical Spacer System

FDA UDI
Choice Spine, LP·00840996164429·BLACKHAWK,STERILE,LORDOTIC,14X12X6

BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)

FDA 510(k)
FDA Class 2 ·Anesthesiology

SPINAL MESH SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code EZX·August 12, 2011

PYRAMESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·September 29, 2015

ASTERX EXPANDABLE CORPECTOMY SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019

ASTERX EXPANDABLE CORPECTOMY SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MQP·March 4, 2019

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·October 26, 2019

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

ETS - ENDOSCOPIC LINEAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 15, 2011

PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code FTL·July 8, 2013

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·June 27, 2020

PYRAMESH C TITANIUM MESH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code EZX·April 22, 2019

SPACELABS XHIBIT CENTRAL STATION

FDA Adverse Event
Malfunction ·SPACELABS HEALTHCARE INC.·Product code MHX·November 24, 2021

ZEVO ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

PYRAMESH® C TITANIUM MESH

FDA Adverse Event
Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code EZX·May 26, 2025