Company
Telefelx Medical
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2010 | Telefelx Medical WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC
The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes Terminated |
GEI | None listed |
| Aug 26, 2010 | Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical. Terminated |
GAM | K991191 |
| Aug 26, 2010 | Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in gener Terminated |
GAM | K905482 |
| Mar 9, 2010 | Telefelx Medical Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30. Terminated |
BTT | K063758 |
| Jan 15, 2010 | Telefelx Medical Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709 Terminated |
BZA | None listed |
| Sep 16, 2008 | Telefelx Medical WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemosta Terminated |
FZP | K021808 |
| Sep 16, 2008 | Telefelx Medical WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and inten Terminated |
FZP | K021808 |
| Sep 16, 2008 | Telefelx Medical Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the applic Terminated |
FZP | K021808 |
| Sep 16, 2008 | Telefelx Medical Weck Hemoclip Plus Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the appl Terminated |
FZP | K021808 |
| Sep 16, 2008 | Telefelx Medical Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for Terminated |
FZP | K021808 |
| Sep 4, 2008 | Telefelx Medical Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only, Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709 Terminated |
GDG | K771187 |
| Sep 4, 2008 | Telefelx Medical Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only. Terminated |
GDG | K771187 |
| Nov 29, 2007 | Telefelx Medical Pilling Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 277 Terminated |
HTD | None listed |
| Nov 29, 2007 | Telefelx Medical Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27 Terminated |
HTD | None listed |
| Nov 29, 2007 | Telefelx Medical Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Manufactured for : Teleflex Medical, Re Terminated |
HTD | None listed |