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Terumo Medical Corporation

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glid recall (Z-2930-2026)Terumo Medical Corporation2026-08-10
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI- recall (Z-1374-2019)Terumo Medical Corporation2019-05-28
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, S recall (Z-1375-2019)Terumo Medical Corporation2019-05-28
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20 recall (Z-1376-2019)Terumo Medical Corporation2019-05-28
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagn recall (Z-2033-2017)Terumo Medical Corporation2017-05-04
PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Intro recall (Z-2738-2016)Terumo Medical Corporation2016-09-06
Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Va recall (Z-1611-2013)Terumo Medical Corporation2013-06-27
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate recall (Z-1612-2013)Terumo Medical Corporation2013-06-27
Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthr recall (Z-2858-2011)Terumo Medical Corporation2011-07-20
Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexibl recall (Z-2798-2011)Terumo Medical Corporation2011-07-13
Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot recall (Z-2415-2011)Terumo Medical Corporation2011-06-06
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot recall (Z-2416-2011)Terumo Medical Corporation2011-06-06
Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, recall (Z-2417-2011)Terumo Medical Corporation2011-06-06

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Every clearance here is in the API, with alerts when new ones post.