18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
FDA 510(k)
FDA Class 2
·Orthopedic
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837066512·16x13 Rasp/Trial 0 deg 5mm No Stop
Verteloc Lordotic Lumbar Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129477·
Verteloc Lordotic Lumbar Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129507·
Zavation
FDA UDI
Zavation LLC·00842166114609·K-Wire, Sharp, Threaded
Zavation
FDA UDI
Zavation LLC·00842166114586·K-Wire, Blunt, Threaded
Verteloc Lordotic Lumbar Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129460·
Zavation
FDA UDI
Zavation LLC·00842166114616·K-Wire, Sharp, Smooth
Verteloc Lordotic Lumbar Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129484·
Zavation
FDA UDI
Zavation LLC·00842166176508·K-Wire, Blunt, Smooth
Zavation
FDA UDI
Zavation LLC·00842166114593·K-Wire, Blunt, Smooth
Verteloc Lordotic Lumbar Cage
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215129491·
WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 21, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
WALLSTENT RX BILIARY ENDOPROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code FGE·August 21, 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