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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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inmode plus system Inmode MD , Ltd. k153568 07/12/2016
infinity(tm) porous-coated trochanteric module Dow Corning Wright k911595 07/12/1991
infant ecg electrode #60-1029 Aspen Laboratories, Inc. k810102 01/29/1981
implantmed si-95 115 (100-130 v) and si-95 230 (220-240 v) W&H Dentalwerk Buermoos GmbH k002469 02/07/2001
immunocap total ige calibrator strip/total ige curve control strip, immunocap total ige calibrators/total ige curve controls, immunocap specific ige calibrator strip/specific ige curve control strip, immunocap specific ige calibrators/specific ige curve controls Phadia AB k161899 07/28/2016
image x-70 plus dental x-ray unit Medical Device Consultants, Inc. k000551 03/16/2000
illico mis posterior fixation system Alphatec Spine, Inc. k123623 02/14/2013
ige enzyme immunoassay test kit cat.no. kif4064 Medix Biotech, Inc. k922047 08/05/1992
identity imprint knee replacement system (including identity imprint posterior stabilized (ps) krs and identity imprint cruciate retaining (cr) krs) Conformis, Inc. k212411 09/23/2021
hypervisor central monitoring system (including telemetry monitoring system, tms-6016) Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. k132036 07/01/2014

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