The Kendal Co.
Mansfield, MA, US
The Kendal Co. appears in FDA device records in Mansfield, MA. FDA records list 63 510(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
- 63
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 63FDA records hold 63 510(k) clearances for The Kendal Co. between 1980 and 2000. The busiest year on record is 1989, with 13. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 6 |
| 1982 | 7 |
| 1983 | 4 |
| 1984 | 6 |
| 1985 | 4 |
| 1986 | 9 |
| 1987 | 5 |
| 1988 | 1 |
| 1989 | 13 |
| 1994 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000087 | MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR | FOZ | Substantially Equivalent | |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C | EZL | Substantially Equivalent | |
| K991758 | MONOJECT INSULIN SYRINGE | FMF | Substantially Equivalent | |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | KOB | Substantially Equivalent | |
| K951488 | KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP | KNY | Substantially Equivalent | |
| K942664 | KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM | JOW | Substantially Equivalent | |
| K942774 | POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING | MGP | Substantially Equivalent for Some Indications | |
| K892434 | KENDALL CURITY OXYGEN MASK | BYG | Substantially Equivalent | |
| K892440 | KENDALL CURITY EXTENSION TUBES | FPA | Substantially Equivalent | |
| K892438 | KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES | FPA | Substantially Equivalent | |
| K892436 | KENDALL CURITY IRRIGATION SYRINGE | KOD | Substantially Equivalent | |
| K892442 | KENDALL CURITY URETHRAL CATHETERS | GBM | Substantially Equivalent | |
| K892439 | KENDALL CURITY STOMACH TUBES | KNT | Substantially Equivalent | |
| K892437 | KENDALL KENGUARD URINARY LEG BAGS | KNX | Substantially Equivalent | |
| K892435 | KENDALL CURITY OXYGEN NASAL CANNULA | CAT | Substantially Equivalent | |
| K892432 | KENDALL CURITY ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | |
| K892441 | KENDALL CURITY SUCTION CATHETERS | BSY | Substantially Equivalent | |
| K892431 | KENDALL CURITY FEEDING TUBES | FPD | Substantially Equivalent | |
| K892433 | KENDALL CURITY URINARY DRAINAGE BAGS | KNX | Substantially Equivalent | |
| K885238 | CURITY CONTINUOUS SPINAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | |
| K881667 | KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH | GBM | Substantially Equivalent | |
| K873111 | CONFORMA(TM) PLASTER BANDAGES | ITG | Substantially Equivalent | |
| K872310 | CURAD MEDICATED PLASTIC STRIPS | CGX | Substantially Equivalent | |
| K871066 | CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY | CAZ | Substantially Equivalent | |
| K871296 | T.E.D.(TM) TRACTION DEVICE | KQZ | Substantially Equivalent | |
| K864103 | CURITY ANESTHESIA FILTER | CAH | Substantially Equivalent | |
| K863581 | MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB | JOW | Substantially Equivalent | |
| K861827 | CURITY CENTRAL VENOUS CATHETERIZATION TRAY | DQY | Substantially Equivalent | |
| K861829 | CURITY CENTRAL VENOUS CATHETER | DQY | Substantially Equivalent | |
| K861828 | CURITY VENOUS CATHETERIZATION KIT | DQY | Substantially Equivalent | |
| K855061 | CURITY PERCUTANEOUS CATHETER INSERTION KIT | DYB | Substantially Equivalent | |
| K855060 | CURITY PERCUTANEOUS CATHETER INSERTION TRAY | DYB | Substantially Equivalent | |
| K860484 | CURITY & KENGUARD SILICONE COATED FOLEY CATHETER | KOD | Substantially Equivalent | |
| K855137 | CURITY FIBEROPTIC INTUBATING AIRWAY | CAE | Substantially Equivalent | |
| K854862 | CURITY URETERAL STENT | FAD | Substantially Equivalent | |
| K852084 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP | KOD | Substantially Equivalent | |
| K852083 | THE KENDALL URINARY OUTPUT MONITOR | FFO | Substantially Equivalent | |
| K853145 | KENDALL CURITY BURN PAD | FPY | Substantially Equivalent for Some Indications | |
| K852085 | KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG | KNX | Substantially Equivalent | |
| K842840 | CURITY SILICONE NEPHROSTOMY CATHETER | LJE | Substantially Equivalent | |
| K842899 | CURITY SUPRAPUBIC DRAINAGE SYSTEM | LJE | Substantially Equivalent | |
| K842898 | CURITY I.V. START KIT | LRS | Substantially Equivalent | |
| K841169 | CURITY RIG FOLEY CATH TRAY | KNX | Substantially Equivalent | |
| K840850 | ANESTHESIA VENTILATOR CIRCUIT | CAI | Substantially Equivalent | |
| K840849 | SCAVENGER TUBING 19MM | CBN | Substantially Equivalent | |
| K833790 | CURITY 100% SILICONE COUDE' CATHETER | KOD | Substantially Equivalent | |
| K832692 | CURITY CATHETER STRAP | KOD | Substantially Equivalent | |
| K832609 | A.V.R. KNEE LENGTH THERAPEUTIC STOCK- | DWL | Substantially Equivalent | |
| K831121 | CURITY LEG BAG | KNX | Substantially Equivalent | |
| K822424 | CURITY TRANSPARENT FILM DRESSING | FRO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- CAEAirway, Oropharyngeal, Anesthesiology
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CAZAnesthesia Conduction Kit
- CBNApparatus, Gas-Scavenging
- ITGBandage, Cast
- GECBrush, Scrub, Operating-Room
- CATCannula, Nasal, Oxygen
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LJECatheter, Nephrostomy
- DQYCatheter, Percutaneous
- EZLCatheter, Retention Type, Balloon
- KOBCatheter, Suprapubic (And Accessories)
- GBMCatheter, Urethral
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- KQZComponent, Traction, Non-Invasive
- FAJCystoscope And Accessories, Flexible/Rigid
- KKXDrape, Surgical, Antimicrobial
- MGPDressing, Wound And Burn, Occlusive
- FRODressing, Wound, Drug
- CAHFilter, Bacterial, Breathing-Circuit
- EFQGauze/Sponge, Internal
- LRSI.V. Start Kit
- DYBIntroducer, Catheter
- BYGMask, Oxygen
- IMDPack, Hot Or Cold, Disposable
- FFORetractor, Self-Retaining
- FPASet, Administration, Intravascular
- FPYSheet, Burn
- JOWSleeve, Limb, Compressible
- FADStent, Ureteral
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- FMFSyringe, Piston
- KGXTape And Bandage, Adhesive
- FPDTube, Feeding
- BTRTube, Tracheal (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain