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

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KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111

FDA 510(k)
FDA Class 2 ·Ophthalmic

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00141231·

Preclean Kit

FDA UDI
MEDIVATORS INC.·40677964010628·Preclean Plus Kit includes DEFENDO Olympus 4-pi...

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001123·artVeneer life lower anteriors, UBL, A35

N/A

FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825002923·Diagnostic EP Catheter, Cournand curve, 4 elect...

TPLIF Interbody System

FDA UDI
Tyber Medical, LLC·M6950020011230·8mm Shavers - Modification - Flat Blade

FREEDOM, MODEL 4660

FDA 510(k)
FDA Unclassified ·Unknown

WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)

FDA 510(k)
FDA Class 2 ·Neurology

iBOT PMD with software version 01.05.24. Personal Mobility Device.

FDA Enforcement
Class II ·Ongoing·Mobius Mobility LLC·June 18, 2025

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·May 30, 2017

BD DISCARDIT II 2 ML SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 13, 2020

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

ACRYSOF RESTOR

FDA Adverse Event
Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·February 17, 2011

INRATIO

FDA Adverse Event
Malfunction ·HEMOSENSE, SJ·Product code JPA·February 15, 2008

BACT/ALERT I NST 100 BTLS - 259785

FDA Adverse Event
Malfunction ·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024

A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.

FDA Enforcement
Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025