Tyco Healthcare
Mansfield, MA, US
Tyco Healthcare appears in FDA device records in Mansfield, MA. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Tyco Healthcare between 2001 and 2007. The busiest year on record is 2004, with 5. The most recent is 2007, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2003 | 2 |
| 2004 | 5 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071049 | DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR | EZL | Substantially Equivalent | |
| K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | |
| K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | |
| K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | FMF | Substantially Equivalent | |
| K042709 | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | EZL | Substantially Equivalent | |
| K040897 | DOVER ROB-NEL CATHETER | KOD | Substantially Equivalent | |
| K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | JOW | Substantially Equivalent | |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | KOD | Substantially Equivalent | |
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE | NGT | Substantially Equivalent | |
| K033453 | KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING | FRO | Substantially Equivalent | |
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | KSR | Substantially Equivalent | |
| K033373 | MONOJECT INSULIN SYRINGE | FMI | Substantially Equivalent | |
| K013556 | MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE | FOZ | Substantially Equivalent | |
| K012736 | MONOJECT SAFETY NEEDLE | FMI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- EZLCatheter, Retention Type, Balloon
- KODCatheter, Urological
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- FRODressing, Wound, Drug
- FMINeedle, Hypodermic, Single Lumen
- NGTSaline, Vascular Access Flush
- JOWSleeve, Limb, Compressible
- FMFSyringe, Piston
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