13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sasmar Vanilla
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT
SASMAR ORIGINAL, SASMAR CLASSIC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CASPIAN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLAR GI SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
UNKNOWN PRODUCT - SET SCREW
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012
COLONRING/COMPRESSION ANASTOMOSIS RING
FDA Adverse Event
Injury
·NOVOGI·Product code FZP·May 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 20, 2008
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
FDA Enforcement
Class II
·Terminated·AMS Diagnostics, LLC·April 2, 2014
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
FDA Enforcement
Class II
·Terminated·AMS Diagnostics, LLC·April 2, 2014
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