13 results · 20ms · Sources: EU EUDAMED, US FDA

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ECHONAVIGATOR RELEASE 1

FDA 510(k)
FDA Class 2 ·Radiology

Z Liquid HT OM2-S 100ml

FDA UDI
ARGEN CORPORATION, THE·D818121781·Dental porcelain/ceramic restoration kit

MacBite

FDA UDI
Surgimac LLC·D10512178EA1·Mac Bite Registration Material - 50ml

SurgiMac

FDA UDI
Surgimac LLC·D12178EA1·Mac Bite Registration Material - 50ml

EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GYMFORM DUAL FLEX BELT MODEL WB-162

FDA 510(k)
FDA Class 2 ·Physical Medicine

CLEARVIEW UTERINE MANIPULATOR

FDA Adverse Event
Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code MBH·August 29, 2016

SCEPTER XC

FDA Adverse Event
Malfunction ·MICROVENTION, INC.·Product code DQY·December 6, 2023

V12 COVERED STENT

FDA Adverse Event
Injury ·ATRIUM MEDICAL CORPORATION·Product code JCT·May 15, 2013

ADVIA CENTAUR

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJE·September 26, 2014

CONSULTA CRT-D

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024