10 results
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26ms
·
Sources: EU EUDAMED, US FDA
THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900
FDA 510(k)
FDA Class 1
·Radiology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909130552·REVELATION DIAMOND 856L-016C - 5 PACK
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154184842·LAG SCREW MODULE
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Purzir Dental Zirconia
FDA 510(k)
FDA Class 2
·Dental
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 4, 2017
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 14, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 2, 2010
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·January 14, 2013
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