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.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Epimed International with 16 510(k) clearances and 11 device recalls. The most recent is a 510(k) clearance dated May 24, 2024: Racz Neurostat RF Generator.
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.
| May 24, 2024 | Racz Neurostat RF GeneratorK232632 · GXD | 510(k) clearances |
| Feb 1, 2021 | Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and iClass II · Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off | Device recalls |
| Apr 27, 2020 | Percutaneous IntroducerK200624 · BSO | 510(k) clearances |
| Jun 18, 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 3Class II · Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains | Device recalls |
| Jun 18, 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 3Class II · Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a | Device recalls |
| Mar 8, 2019 | Rulo Radiofrequency Lesion ProbeK190256 · GXI | 510(k) clearances |
| Apr 22, 2016 | 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of Class II · There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occ | Device recalls |
| May 28, 2014 | SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)K133316 · BSO | 510(k) clearances |
| Feb 7, 2008 | RK EPIDURAL NEEDLEK072005 · BSP | 510(k) clearances |
| Feb 17, 2006 | RX EPIDURAL NEEDLEK053318 · BSP | 510(k) clearances |
| Aug 26, 2005 | STINGRAY EPIDURAL CATHETER CONNECTORK051171 · CAZ | 510(k) clearances |
| Aug 22, 2005 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837K051860 · MIA | 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
