8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WONDFO MULTI-DRUG URINE TEST CUP, PANEL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HANSSON PIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
U-BLADE SET, TI GAMMA3 10.5X90MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 30, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014
AEQUALIS
FDA Adverse Event
Injury
·TORNIER SAS·Product code KWS·May 23, 2013
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
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