Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & JohnsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list Cordis US with 22 device recalls and 4 510(k) clearances. The most recent is a device recall dated Mar 4, 2025: Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, Steril….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 4, 2025 | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx OnlyClass II · product mix-up; Vascular stent labeled as one size but contains a different size. | Device recalls |
| Mar 4, 2025 | Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx OnlyClass II · product mix-up; Vascular stent labeled as one size but contains a different size. | Device recalls |
| Feb 7, 2025 | Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introductClass II · Catheter manufactured at the incorrect length. | Device recalls |
| Jun 28, 2024 | Cordis BRITECROSS Support CatheterK233637 · DQY | 510(k) clearances |
| Nov 28, 2023 | MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.Class II · Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of Myn | Device recalls |
| Nov 28, 2023 | MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sitesClass II · Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of Myn | Device recalls |
| Nov 21, 2023 | INFINITI™ Ambi Angiographic CatheterK232573 · DQO | 510(k) clearances |
| Sep 26, 2023 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheterClass I · Non-sterile product labeled as sterile was distributed. | Device recalls |
| Apr 24, 2023 | RAIN Sheath™ Tibial Pedal IntroducerK230704 · DYB | 510(k) clearances |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RECClass I · There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are | Device recalls |
| Mar 24, 2023 | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMClass I · There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are | Device recalls |
| Aug 22, 2022 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterK221832 · LIT | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
