15 results · 21ms · Sources: EU EUDAMED, US FDA

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CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)

FDA 510(k)
FDA Class 2 ·Dental

LEONE SPA

FDA UDI
LEONE SPA·08033707014270·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 9

ARx SAI

FDA UDI
Life Spine, Inc.·00190837196196·

ARx SAI

FDA UDI
Life Spine, Inc.·00190837194727·

Arx

FDA UDI
Life Spine, Inc.·00190837175719·

TRIMED CLAVICLE FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

M-BOLUS EMBOLIC MICROSPHERES

FDA 510(k)
FDA Class 2 ·Neurology

HUDSON CONCHA NEPTUNE

FDA Adverse Event
Malfunction ·TELEFLEX·Product code BTT·October 6, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·June 7, 2013

HUDSON NEBULIZER, ADAPTORS 033

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code CAF·June 21, 2011

SVO2 CCO OPTIQ CATHETER

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code DQE·May 20, 2013

VITROS Chemistry Products COCM Reagent

FDA Enforcement
Class II ·Terminated·Ortho-Clinical Diagnostics·January 29, 2014

7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·July 26, 2017

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 26, 2014