Epimed International, Inc.
Epimed International, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2020, with 4 FDA device recalls on record.
Top product codes for Epimed International, Inc.
FDA recalls by Epimed International, Inc.
- Z-1276-2021 — Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
- Z-2069-2019 — Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
- Z-2068-2019 — Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
- Z-0086-2017 — 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
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 Epimed International, Inc.
- K200624 — Percutaneous Introducer
- K190256 — Rulo Radiofrequency Lesion Probe
- K133316 — SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
- K053318 — RX EPIDURAL NEEDLE
- K051171 — STINGRAY EPIDURAL CATHETER CONNECTOR
- K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
- K043467 — FLEXIBLE SPINAL NEEDLE
- K041021 — RF INTRODUCTION CANNULA
- K041843 — PENCIL POINT NEEDLE
- K023140 — VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
- K030562 — TUOHY EPIDURAL NEEDLE
- K022029 — QUINCKE SPINAL NEEDLE
- K020926 — EXTENSION SET, MODELS 1911-512
- K981329 — FETH-R-KATH
Data sourced from openFDA. This site is unofficial and independent of the FDA.