11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750004508·VITROS Chemistry Products TDM Performance Verif...
UniTip Catheter
FDA UDI
Unisensor AG·07640172973875·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973790·
MSA HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 17, 2014
FABIUS GS
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL GMBH·Product code BSZ·July 25, 2011
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL -NEUROMODULATION·Product code LGW·June 14, 2013
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.
FDA Recall
Terminated
·Revmedx Inc·Product code NAB·August 12, 2015
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
FDA Enforcement
Class II
·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026