Terumo Medical Corporation
Terumo Medical Corporation holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2023, with 19 FDA device recalls on record.
Top product codes for Terumo Medical Corporation
FDA recalls by Terumo Medical Corporation
10 most recent of 19- Z-2930-2026 — GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
- Z-1374-2019 — SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath¿ Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure.
- Z-1375-2019 — SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
- Z-1376-2019 — Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- Z-2004-2019 — Terumo Needle, 18G x 1", Product Code NN1825R
- Z-2006-2019 — Terumo Needle, 30G x 1/2", Product Code NN3013R
- Z-1999-2019 — Terumo Sur-vet Needle, 22G x 1", Product Code 100211
- Z-2003-2019 — Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
- Z-1998-2019 — Terumo Sur-vet Needle, 20G x 1", Product Code 100204
- Z-2000-2019 — Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Terumo Medical Corporation
- K231044 — R2P Navicross
- K213531 — TR BAND Radial Compression Device
- K193125 — R2P Destination Slender Guiding Sheath
- K181237 — Glidesheath Slender Tibial Pedal Kit
- K173831 — Glidesheath Slender
- K172995 — Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
- K171491 — R2P Destination Slender Guiding Sheath
- K152173 — Glidesheath
- K152525 — TR BAND Radial Compression Device
- K151471 — Radifocus Glidewire Endoscopic Wire
- K142183 — GLIDESHEATH SLENDER
- K122590 — RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
- K122980 — GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
- K112382 — TERUMO ASPRIATION CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.