Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US
Kendall Healthcare Products Co. Div.Of Tyco Health appears in FDA device records in Mansfield, MA. FDA records list 66 510(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
- 66
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 66FDA records hold 66 510(k) clearances for Kendall Healthcare Products Co. Div.Of Tyco Health between 1989 and 1997. The busiest year on record is 1993, with 16. The most recent is 1997, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 5 |
| 1990 | 9 |
| 1991 | 4 |
| 1992 | 5 |
| 1993 | 16 |
| 1994 | 9 |
| 1995 | 6 |
| 1996 | 3 |
| 1997 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973763 | KENDALL CURITY IODOFORM PACKING STRIP | EFQ | Substantially Equivalent | |
| K973511 | KENDALL CURITY PETROLATUM GAUZE | FRO | Substantially Equivalent for Some Indications | |
| K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | FRO | Substantially Equivalent for Some Indications | |
| K973619 | KENDALL CURITY NON-ADHERING DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K973509 | KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K973546 | KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER | EZD | Substantially Equivalent | |
| K970266 | KENDALL HYDROPHILIC POWDER WOUND DRESSING | KGN | Substantially Equivalent for Some Indications | |
| K963446 | KENDALL DUAL LUMEN CATHETER | MPB | Substantially Equivalent | |
| K964899 | KENDALL CURITY URETERAL CATHETER | EYB | Substantially Equivalent | |
| K964519 | CURITY THORACENTESIS TRAY | GCX | Substantially Equivalent | |
| K961977 | KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE | CBI | Substantially Equivalent | |
| K954706 | KENDALL BLUNT TUOHY EPIDURAL NEEDLE | CAZ | Unknown | |
| K953766 | KENDALL SAFETAP SPINAL ANESTHESIA TRAY | CAZ | Unknown | |
| K953511 | KENDALL SHERIDAN CPAP SYSTEM | BYE | Unknown | |
| K950775 | CURASORB ZN ALGINATE WOUND DRESSING | KMF | Substantially Equivalent | |
| K950412 | CURAGEL HYDROGEL WOUND DRESSING | NAE | Substantially Equivalent | |
| K945675 | PREPPIES SKIN BARRIER WIPE | FRO | Substantially Equivalent | |
| K946269 | CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS | KMF | Substantially Equivalent | |
| K944468 | KERLIX ZINC SALINE DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K944236 | NEEDLELESS URINE SAMPLING PORT | KNX | Substantially Equivalent | |
| K943636 | CURADERM ALGINATE HYDROCOLLOID | KMF | Substantially Equivalent for Some Indications | |
| K944251 | KENDALL MODU-VAC CLOSED SUCTION SYSTEM | BSY | Substantially Equivalent | |
| K943073 | CURAFIL WOUND GEL DRESSING | MGQ | Substantially Equivalent for Some Indications | |
| K942459 | CURASALT HYPERTONIC SALINE DRESSING | KMF | Substantially Equivalent | |
| K941493 | KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT | CAZ | Unknown | |
| K940574 | TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGE | EFQ | Substantially Equivalent | |
| K935774 | CURITY FAST-CATH FEMALE CATHETER KIT | EYT | Unknown | |
| K933689 | MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING | KMF | Substantially Equivalent | |
| K933400 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR | KOD | Substantially Equivalent | |
| K933399 | KENDALL URODYNAMIC CATHETERS | FEN | Substantially Equivalent | |
| K933259 | SCD(R) CONTROLLER | JOW | Substantially Equivalent | |
| K932835 | KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE | JOW | Substantially Equivalent | |
| K931459 | KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER | KNX | Substantially Equivalent | |
| K925417 | KENDALL HOME RX THERAPEUTIC STOCKING | DWL | Substantially Equivalent | |
| K930551 | KENDALL UNIVERSAL EXTENSION SET | GBX | Substantially Equivalent | |
| K930219 | KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE | BSO | Substantially Equivalent | |
| K922162 | CURITY PLASTIC LOSS OF RESISTANCE SYRINGE | CAZ | Substantially Equivalent | |
| K925989 | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | GCY | Substantially Equivalent | |
| K925805 | KENDALL WOUND DRAINAGE SYSTEMS-TROCARS | GBX | Substantially Equivalent | |
| K925749 | KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML | GCY | Substantially Equivalent | |
| K921288 | CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE | BSP | Substantially Equivalent | |
| K925748 | KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN | GBX | Substantially Equivalent | |
| K925001 | CURITY CALCIUM ALGINATE WOUND DRESSING | KMF | Substantially Equivalent | |
| K922113 | KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH | BSO | Substantially Equivalent | |
| K921054 | KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. | KOD | Substantially Equivalent | |
| K921055 | KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER | KNY | Substantially Equivalent | |
| K920252 | CURAD KID SIZE INSTANT COLD PACK | IMD | Substantially Equivalent | |
| K915635 | CURITY VENTED DRESSING SYSTEM | MGP | Substantially Equivalent | |
| K910791 | CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING | BSP | Substantially Equivalent | |
| K911258 | KENDALL PEDIATRIC URINE METER | EXR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNYAccessories, Catheter, G-U
- CAZAnesthesia Conduction Kit
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- KMFBandage, Liquid
- JOLCatheter And Tip, Suction
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- BSOCatheter, Conduction, Anesthetic
- MPBCatheter, Hemodialysis, Non-Implanted
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- EZDCatheter, Straight
- LFJCatheter, Subclavian
- EYBCatheter, Ureteral, Gastro-Urology
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- FENDevice, Cystometric, Hydraulic
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- MGPDressing, Wound And Burn, Occlusive
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- EFQGauze/Sponge, Internal
- LYYLatex Patient Examination Glove
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- IMDPack, Hot Or Cold, Disposable
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- JOWSleeve, Limb, Compressible
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- EXRUrinometer, Mechanical
- KGNWound Dressing With Animal-Derived Material(S)
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Kendall Healthcare Products Co. Div.Of Tyco Health edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Kendall Healthcare Products Co. Div.Of Tyco Health. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain