Medical Device Manufacturer · US , Mansfield , MA

Tyco Healthcare

14 submissions · 14 cleared · Since 2001
14
Total
14
Cleared
0
Denied

Tyco Healthcare — FDA 510(k) Submissions

Tyco Healthcare has submitted 14 FDA 510(k) premarket notifications since 2001, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dressing, Wound, Drug, Catheter, Urological, Catheter, Retention Type, Balloon, Needle, Hypodermic, Single Lumen, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
K071049 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
Oct 2007 186d
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
K070685 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Sep 2007 186d
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
K070653 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Sep 2007 187d
MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
K061492 · FMF Syringe, Piston · General Hospital
Aug 2006 64d
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
K042709 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
Jan 2005 110d
DOVER ROB-NEL CATHETER
K040897 · KOD Catheter, Urological · Gastroenterology & Urology
Jul 2004 105d
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
K040649 · JOW Sleeve, Limb, Compressible · Cardiovascular
Jul 2004 126d
DOVER RED RUBBER ROBINSON CATHETER
K041243 · KOD Catheter, Urological · Gastroenterology & Urology
Jul 2004 57d
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
K032438 · NGT Saline, Vascular Access... · General Hospital
Jun 2004 328d
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
K033453 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Apr 2004 182d
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
K032827 · KSR Container, Empty, For... · Hematology
Dec 2003 89d
MONOJECT INSULIN SYRINGE
K033373 · FMI Needle, Hypodermic,... · General Hospital
Nov 2003 22d
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
K013556 · FOZ Catheter, Intravascular,... · General Hospital
Dec 2001 67d
MONOJECT SAFETY NEEDLE
K012736 · FMI Needle, Hypodermic,... · General Hospital
Oct 2001 70d
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