12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024
VENTURI PHACO PACK
FDA 510(k)
FDA Class 2
·Ophthalmic
E3 TORQUE CONTROL MOTOR
FDA 510(k)
FDA Class 1
·Dental
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 29, 2013
ZIMMER REVERSE CUSTOM BASE PLATE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·June 16, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 7, 2015
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