FDA 510(k) Applications Submitted by Michael R. Johnson
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K960086 |
01/11/1996 |
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM |
SLT-J LTD. |
K000210 |
01/24/2000 |
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT |
MEDTRONIC VASCULAR |
K090639 |
03/10/2009 |
EXELO2, MODEL 4010 |
QUANTEL DERMA GMBH |
K050877 |
04/06/2005 |
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR |
BIOSENSE WEBSTER, INC. |
K081095 |
04/17/2008 |
PROLITE III TOWER AND PR AND HR HANDPIECE |
QUANTEL S.A. |
K102027 |
07/19/2010 |
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM |
QUANTEL MEDICAL S.A. |
K152046 |
07/23/2015 |
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) |
ART OPTICAL CONTACT LENS, INC. |
K142641 |
09/17/2014 |
Intelliwave4 |
ART OPTICAL CONTACT LENS, INC. |
K970069 |
01/08/1997 |
DUAL HOOK FIBEROPTIC DELIVERY SYSTEM |
IHD, INC. |
K960905 |
03/05/1996 |
SDL DIODE LASER SYSTEM |
SLT-J LTD. |
K964031 |
10/08/1996 |
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM |
SLT-J LTD. |
K171968 |
06/30/2017 |
EchoGlo Needle |
Smiths Medical ASD, Inc. |
K172410 |
08/09/2017 |
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters |
Smiths Medical ASD, Inc. |
K172592 |
08/29/2017 |
CADD Yellow High Volume Administration Set with NRFit connector |
Smiths Medical ASD, Inc. |
K172800 |
09/18/2017 |
Portex« Lancet Point Spinal Needles with NRFitÖ connectors, Portex« Pencil Point Spinal Needles with NRFitÖ connectors |
Smiths Medical ASD, Inc. |
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