Medical Device Manufacturer · US , Mansfield , MA

Tyco Healthcare - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2001

Recent clearances: DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR, KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662, KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662

View 14 510(k) Devices ↓

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tyco Healthcare General Hospital ✕

5 devices

1-5 of 5

Cleared Aug 03, 2006

MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE

General Hospital · 64d

Cleared Jun 30, 2004

MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET...

General Hospital · 328d

Cleared Nov 13, 2003

MONOJECT INSULIN SYRINGE

General Hospital · 22d

Cleared Dec 31, 2001

MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE

General Hospital · 67d

Cleared Oct 25, 2001

MONOJECT SAFETY NEEDLE

General Hospital · 70d