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