13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISCOVERY PET/CT 710
FDA 510(k)
FDA Class 2
·Radiology
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
SAPPHIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2024
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DRA·October 1, 2014
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·May 1, 2013
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 20, 2011
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
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