Company ยท US
Kendall
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2009. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | 9 |
| FEG | Tube, Double Lumen For Intestinal Decompression And/Or Intubation | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 |
| FLL | Continuous Measurement Thermometer | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| JOW | Sleeve, Limb, Compressible | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 |
| NAD | Dressing, Wound, Occlusive | 1 |
| NFK | Kit, Repair, Catheter, Hemodialysis | 1 |
| NGT | Saline, Vascular Access Flush | 1 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2009 | K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT Kendall | NFK |
| Nov 3, 2006 | K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) Kendall | MSD |
| Aug 9, 2006 | K061936 | KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 The Kendall Company | LJS |
| Aug 4, 2006 | K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) Kendall | MSD |
| Jan 6, 2006 | K053410 | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR Kendall | FEG |
| Oct 6, 2005 | K051584 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY Kendall | MSD |
| Dec 22, 2004 | K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP Kendall | MSD |
| Dec 10, 2004 | K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 Kendall | LJS |
| Nov 5, 2004 | K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR Kendall | KNT |
| Sep 27, 2004 | K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER Kendall | MSD |
| May 19, 2004 | K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR Kendall | MSD |
| May 17, 2004 | K040388 | NEXT GENERATION SALEM SUMP Kendall | FEG |
| Feb 20, 2004 | K033676 | PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER Kendall | MSD |
| May 13, 2003 | K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR The Kendall Company | MPB |
| Apr 10, 2002 | K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR The Kendall Company | NIE |
| Oct 15, 2001 | K011283 | MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE The Kendall Company | NGT |
| Aug 22, 2001 | K011941 | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 The Kendall Company | FRO |
| Apr 9, 2001 | K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS The Kendall Company | MSD |
| Mar 28, 2001 | K002901 | KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER The Kendall Company | MSD |
| Jan 11, 2001 | K003313 | FILAC FAS TEMP ELECTRONIC THERMOMETER The Kendall Company | FLL |
| Jan 31, 2000 | K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING The Kendall Company, L.P. | NAD |
| Sep 29, 1999 | K992079 | KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 The Kendall Company, L.P. | JOW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||