21 results · 31ms · Sources: EU EUDAMED, US FDA

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IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ

FDA 510(k)
FDA Class 2 ·Orthopedic

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040044995·Burnisher SE 33

EndoGator Hybrid

FDA UDI
MEDIVATORS INC.·00724995224226·EndoGator Tubing Hybrid, Fuji 700, used with t...

Zemits Leger

FDA UDI
Advance-Esthetic LLC·00860010841105·Large-area electric massager

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159002850·Jacobson Micro Needle Holder Round Handle

MEDTRONIC TRANSCATHETER DELIVERY SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·September 26, 2025

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·September 26, 2025

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

HARDYDISK, CARBENICILLIN, 100MCG

FDA 510(k)
FDA Class 2 ·Microbiology

CIDEX OPA SOLUTION

FDA 510(k)
FDA Class 2 ·General Hospital

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·May 27, 2025

Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code FZW·August 8, 2023

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2014

OT VERIO IQ METER

FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

BD ECLIPSE

FDA Adverse Event
Malfunction ·BD·Product code FMI·February 22, 2011

Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

FDA Enforcement
Class II ·Terminated·Insulet Corporation·March 17, 2021

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024