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

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BT-200V VASCULAR DOPPLER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII

ArgenZ Anterior 95x16 #1

FDA UDI
ARGEN CORPORATION, THE·D818121267·Dental porcelain/ceramic restoration kit

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450725504·

Sun Nuclear Corporation

FDA registration
Sun Nuclear Corporation·5 products·🇺🇸 United States

CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)

FDA 510(k)
FDA Class 2 ·Ophthalmic

PREMIO 10 MOXA

FDA 510(k)
FDA Class 2 ·Physical Medicine

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026

ADAPTA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NVZ·April 12, 2022

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025

LEAD MODEL UNKNOWN

FDA Adverse Event
Injury ·CYBERONICS·Product code LYJ·May 20, 2013

ACCU-CHEK AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2011

FLEX 60 ENDO LINEAR CUTTER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 18, 2008

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025

NC QUANTUM APEX?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026

NC QUANTUM APEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 26, 2026

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026