16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
MEDTRONIC, INC.·00681490026901·ACCESSORY 080118 ADHESIVE STERILE
NA
FDA UDI
MEDTRONIC, INC.·00763000059446·ADHESIVE 080118 MEDICAL OUS US EIFU
NA
FDA UDI
MEDTRONIC, INC.·00613994618139·ADHESIVE 080118 MEDICAL INTL US
Regent
FDA UDI
SPINAL ELEMENTS·00840916114763·Regent ACP 1-Level, 18mm
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604626·ARMBOARD REGULAR, PAD 3"
Slimplicity Anterior Cervical Plate System
FDA UDI
PRECISION SPINE, INC.·00815362021118·1 Level 18mm Plate
RAPID PROGRAMMAR
FDA 510(k)
FDA Class 2
·Neurology
NORMED MANDIBULAR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2021
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 6, 2011
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008
CLARIA MRI CRT-D SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NIK·March 4, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014