11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
FDA 510(k)
FDA Class 2
·Physical Medicine
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252713111·Delta 1.7mm Panel 2x21 Ctrsinks x 0.75mm
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
FDA 510(k)
FDA Class 2
·Ophthalmic
BI-PHASIC INFILTRATOR
FDA 510(k)
FDA Class 2
·General Hospital
TI MATRIXNEURO SCREW SELF-DRILLING 4MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·December 21, 2016
ASCENDRA INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·May 3, 2013
JUVEDERM VOLUMA XC 27G 2 X 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·August 21, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 18, 2011
INNOVA 3100-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015