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FDA 510(k) Applications Submitted by KIM K LEE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180497
02/26/2018
Scone Mask
ResMed Ltd
K112489
08/29/2011
SWIFT FX BELLA
RESMED LTD.
K171212
04/25/2017
AirFit N20
ResMed Ltd
K161978
07/18/2016
AirFit N20
ResMed Ltd
K153673
12/21/2015
AirFit N20
ResMed Ltd
K070937
04/04/2007
MULTIPLE BRAND MALE LATEX CONDOM
NULATEX SDN. BHD.
K955706
12/15/1995
JPI AUTOMATIC X-RAY FILM PROCESSOR
JPI HEALTHCARE CO., LTD
K090872
03/30/2009
MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
CARDICA, INC.
K091017
04/09/2009
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
CARDICA, INC.
K150372
02/13/2015
VERASENSE Knee System
OrthoSensor, Inc.
K130380
02/14/2013
ORTHOSENSOR KNEE BALANCER
ORTHOSENSOR, INC.
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