7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEPARIN LOCK / FLUSH SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
VIGNET TELEHEALTH MANAGER
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
FDA 510(k)
FDA Class 2
·Dental
UNIDENTIFIED HIP IMPLANT OR INSTRUMENT
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 29, 2013
INNOVA 2121 - IQ
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS S.C.S.·Product code MQB·June 15, 2011
ZIMMER, INC.
FDA Adverse Event
Injury
·ZIMMER·Product code KWA·June 12, 2008
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