13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HHM
FDA UDI
Oticon A/S·05707131256300·H160, MINIBTE 312 WL 85 CBE HHM
MBCP
FDA 510(k)
FDA Class 2
·Orthopedic
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMP TM 4.7MM MTX FULL, 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 27, 2024
BD NANO¿ 2ND GEN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·July 22, 2022
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 1, 2014
PRISMAFLEX TPE
FDA Adverse Event
Injury
·GAMBRO INDUSTRIES·Product code LKN·May 29, 2013
ADVIA CENTAUR XP HBSAG ASSAY
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·June 17, 2011
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
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code HBC·March 26, 2018
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