10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EYELID SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
TwinFix
FDA UDI
Stryker GmbH·04546540362193·CANNULATED COMPRESSION SCREW
UniTip Catheter
FDA UDI
Unisensor AG·07640172971666·
IVAS 10MM AND 15MM BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Orthopedic
POLY STAT SERUM/URINE HCG TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 14, 2014
RETROFLEX 3 INTRODUCER SHEATH SET
FDA Adverse Event
Injury
·Product code DYB·November 13, 2012
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 2, 2010
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018