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FDA 510(k) Applications Submitted by Mary Rose
FDA 510(k) Number
Submission Date
Device Name
Applicant
K090398
02/17/2009
PROVENT PROFESSIONAL SLEEP APNEA THERAPY
VENTUS MEDICAL, INC.
K051041
04/25/2005
INSULIN PUMP
ABBOTT DIABETES CARE INC.
K171332
05/08/2017
Artemis Neuro Evacuation Device
Penumbra, Inc.
K102397
08/24/2010
KYPHON XPEDE BONE CEMENT
Medtronic
K062770
09/15/2006
COPILOT HEALTH MANAGEMENT SYSTEM
ABBOTT DIABETES CARE INC.
K152699
09/21/2015
Apollo System
PENUMBRA, INC.
K183296
11/27/2018
REAL Immersive System
Penumbra, Inc.
K093828
12/14/2009
KYPH X HV-R BONE CEMENT
MEDTRONIC INC.
K123902
12/18/2012
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
OKTX LLC
K002104
07/12/2000
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF
K022719
08/15/2002
PHYSICAL MONITORING REGISTRATION UNIT
MARYROSE CUSIMANO, PH.D./PHIL REASTON
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