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FDA 510(k) Applications Submitted by TYCO HEALTHCARE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K032438
08/07/2003
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
TYCO HEALTHCARE
K033373
10/22/2003
MONOJECT INSULIN SYRINGE
TYCO HEALTHCARE
K012736
08/16/2001
MONOJECT SAFETY NEEDLE
TYCO HEALTHCARE
K013556
10/25/2001
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
TYCO HEALTHCARE
K040649
03/11/2004
KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
TYCO HEALTHCARE
K032827
09/10/2003
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
TYCO HEALTHCARE
K033453
10/30/2003
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
TYCO HEALTHCARE
K061492
05/31/2006
MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
TYCO HEALTHCARE
K070653
03/09/2007
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
TYCO HEALTHCARE
K070685
03/12/2007
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
TYCO HEALTHCARE
K040897
04/06/2004
DOVER ROB-NEL CATHETER
TYCO HEALTHCARE
K071049
04/13/2007
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
TYCO HEALTHCARE
K041243
05/11/2004
DOVER RED RUBBER ROBINSON CATHETER
TYCO HEALTHCARE
K042709
09/30/2004
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
TYCO HEALTHCARE
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