16 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERFIX ILIAC SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CRILE-WOOD NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896022010·CRILE-WOOD NEEDLE HOLDER STRAIGHT TUNGSTEN CARB...
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837043971·18mm Aileron Assy
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837043988·Aileron-TR Core Assembly, 10mm-18mm, Short
ADEPT 1064/532/755 LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPACT PIEZO P2K, POWERCARE
FDA 510(k)
FDA Class 2
·Dental
IMP TM 4.7MM MTX FULL, 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 27, 2024
FUJIFILM 600 SERIES ENDOSCOPE EC-600WM
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·January 22, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 29, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·June 14, 2011
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
IMP TM 4.7MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 30, 2024
IMP TM 6.0MM MTX FULL, 10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 29, 2023
BD BBL¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code KZI·October 3, 2022
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015