Epimed International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 16
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1276-2021 | Class II | Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 | February 1, 2021 |
| Z-1850-2020 | Class II | R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01) | February 21, 2020 |
| Z-1849-2020 | Class II | R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01) | February 21, 2020 |
| Z-2069-2019 | Class II | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 18 | June 18, 2019 |
| Z-2068-2019 | Class II | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 18 | June 18, 2019 |
| Z-2313-2021 | Class II | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile | December 28, 2017 |
| Z-2312-2021 | Class II | NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile | December 28, 2017 |
| Z-0089-2018 | Class II | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile | July 24, 2017 |
| Z-0088-2018 | Class II | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve | July 24, 2017 |
| Z-0087-2018 | Class II | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Win | July 24, 2017 |
| Z-0086-2017 | Class II | 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, direc | April 22, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232632 | Racz Neurostat RF Generator | May 24, 2024 |
| K200624 | Percutaneous Introducer | April 27, 2020 |
| K190256 | Rulo Radiofrequency Lesion Probe | March 8, 2019 |
| K133316 | SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA | May 28, 2014 |
| K072005 | RK EPIDURAL NEEDLE | February 7, 2008 |
| K053318 | RX EPIDURAL NEEDLE | February 17, 2006 |
| K051171 | STINGRAY EPIDURAL CATHETER CONNECTOR | August 26, 2005 |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | August 22, 2005 |
| K043467 | FLEXIBLE SPINAL NEEDLE | March 31, 2005 |
| K041021 | RF INTRODUCTION CANNULA | September 16, 2004 |
| K041843 | PENCIL POINT NEEDLE | August 24, 2004 |
| K023140 | VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124 | August 15, 2003 |
| K030562 | TUOHY EPIDURAL NEEDLE | April 3, 2003 |
| K022029 | QUINCKE SPINAL NEEDLE | July 30, 2002 |
| K020926 | EXTENSION SET, MODELS 1911-512 | July 12, 2002 |
| K981329 | FETH-R-KATH | August 26, 1998 |