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FDA 510(k) Applications Submitted by ROAIDA JOHNSON
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150285
02/05/2015
Leva(TM) Spacer System
SPINE WAVE, INC.
K180429
02/16/2018
Advincula Delineator Uterine Manipulator
CooperSurgical, Inc.
K170660
03/03/2017
Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
CooperSurgical, Inc.
K180740
03/22/2018
VitriGuard
ORIGIO a/s
K151845
07/07/2015
Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
COOPERSURGICAL, INC.
K142101
08/01/2014
ABACUS (TM) SPACER SYSTEM
SPINE WAVE, INC.
K162833
10/11/2016
VitriGuard
ORIGIO A/S
K142980
10/15/2014
Proficient (TM) Facet Screw Spine System
SPINE WAVE, INC.
K142996
10/16/2014
StaXx(R) XD System
SPINE WAVE, INC.
K182959
10/25/2018
Wallace Dual Lumen Oocyte Recovery System
CooperSurgical Inc.
K153092
10/26/2015
Ally Uterine Positioning System
CooperSurgical, Inc.
K183020
11/01/2018
Endosee System
CooperSurgical, Inc.
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