9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SHIRAZ POSTERIOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARCHITECT IVANCOMYCIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD¿ NESTABLE NON-VENT SHARPS COLLECTOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·June 21, 2023
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LEH·May 20, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014
ENDO STITCH PLYSORB 0 48 VIO DLU SU
FDA Adverse Event
Malfunction
·COVIDIEN LP, FORMERLY US SURG·Product code KOG·May 1, 2013
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·June 20, 2011
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