17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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