Kendall
Mansfield, MA, US
Kendall appears in FDA device records in Mansfield, MA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Kendall between 1999 and 2009. The busiest year on record is 2004, with 7. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 7 |
| 2005 | 1 |
| 2006 | 4 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K092797 | ACUTE AND CHRONIC CATHETER REPAIR KIT | NFK | Unknown | |
| K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) | MSD | Unknown | |
| K061936 | KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 | LJS | Substantially Equivalent | |
| K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) | MSD | Substantially Equivalent | |
| K053410 | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR | FEG | Substantially Equivalent | |
| K051584 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY | MSD | Substantially Equivalent | |
| K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP | MSD | Substantially Equivalent | |
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 | LJS | Substantially Equivalent | |
| K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR | KNT | Substantially Equivalent | |
| K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | |
| K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | MSD | Substantially Equivalent | |
| K040388 | NEXT GENERATION SALEM SUMP | FEG | Substantially Equivalent | |
| K033676 | PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | |
| K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR | MPB | Substantially Equivalent | |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | NIE | Substantially Equivalent | |
| K011283 | MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE | NGT | Substantially Equivalent | |
| K011941 | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 | FRO | Substantially Equivalent | |
| K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS | MSD | Substantially Equivalent | |
| K002901 | KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER | MSD | Substantially Equivalent | |
| K003313 | FILAC FAS TEMP ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | NAD | Substantially Equivalent | |
| K992079 | KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 | JOW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MSDCatheter, Hemodialysis, Implanted
- MPBCatheter, Hemodialysis, Non-Implanted
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FLLContinuous Measurement Thermometer
- FRODressing, Wound, Drug
- NADDressing, Wound, Occlusive
- NFKKit, Repair, Catheter, Hemodialysis
- NGTSaline, Vascular Access Flush
- JOWSleeve, Limb, Compressible
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain