HKI

Product Code: HKI


Products Classified as HKI

4168Camera, Ophthalmic, Ac-poweredOphthalmic Camera.

Total Product Life Cycle (TPLC) Devices

4168Camera, Ophthalmic, Ac-poweredOphthalmic Camera.

FDA Consensus Standards

Camera, Ophthalmic, Ac-Powered [29877]21 CFR §886.1120 🔎
Camera, Ophthalmic, Ac-Powered [34468]21 CFR §886.1120 🔎
Camera, Ophthalmic, Ac-Powered [38751]21 CFR §886.1120 🔎

Pre-market Notifications for HKI

K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation
K203500RetCam EnvisionNatus Medical Incorporated DBA Excel-Tech Ltd. (Xltek)
K202221VX650Luneau Technology Operations
K202097Fundus CameraHuvitz Co., Ltd.
K201122Canon Non-mydriatic Retinal Camera CR SeriesCanon Inc.
K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics
K193319XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical Inc.
K191945KOWA Nonmyd 8Kowa Company, Ltd.
K190954Fundus CameraChongqing Bio NewVision Medical Equipment Ltd.
K190573KOWA DR-1aKowa Company, Ltd.
K190198Microperimeter MP-3, Microperimeter MP-3 Type SNidek Co., Ltd
K1830593nethra NeoForus Health Pvt. Ltd.
K182506LipiScan Dynamic Meibomian ImagerTearScience, Inc.
K182263RetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical Incorporated
K182199NFC-700 Non-mydriatic Auto Fundus CameraCrystalvue Medical Corporation

Global Unique Device Identification Database

00627843652021Camera, Ophthalmic, Ac-Powered
00811608018638Camera, Ophthalmic, Ac-Powered
00811608018621Camera, Ophthalmic, Ac-Powered
00811608018614Camera, Ophthalmic, Ac-Powered
00811608018577Camera, Ophthalmic, Ac-Powered
00811608018560Camera, Ophthalmic, Ac-Powered
00811608018003Camera, Ophthalmic, Ac-Powered
00811608017969Camera, Ophthalmic, Ac-Powered
00811608017822Camera, Ophthalmic, Ac-Powered
00811608017815Camera, Ophthalmic, Ac-Powered
00811608017808Camera, Ophthalmic, Ac-Powered
00899281002137Camera, Ophthalmic, Ac-Powered
00899281002120Camera, Ophthalmic, Ac-Powered
00899281002113Camera, Ophthalmic, Ac-Powered
00864218000104Camera, Ophthalmic, Ac-Powered

Maude Adverse Events

MERGE EYE STATIONMERGE HEALTHCARE2018-12-11
MERGE EYE STATIONMERGE HEALTHCARE2018-12-11
MERGE EYE STATIONMERGE HEALTHCARE2018-11-29
MERGE EYE STATIONMERGE HEALTHCARE2018-11-07
MERGE EYE STATIONMERGE HEALTHCARE2018-08-27
MERGE EYE STATIONMERGE HEALTHCARE2018-08-15
MERGE EYE STATIONMERGE HEALTHCARE2018-07-30
MERGE EYE STATIONMERGE HEALTHCARE2018-07-21
MERGE EYE STATIONMERGE HEALTHCARE2018-07-11
MERGE EYE STATIONMERGE HEALTHCARE2018-06-27
MERGE EYE STATIONMERGE HEALTHCARE2018-05-02
MERGE EYE STATIONMERGE HEALTHCARE2018-04-20
MERGE EYE STATIONMERGE HEALTHCARE2018-02-16
MERGE EYE STATIONMERGE EYE STATION2018-01-19
MERGE EYE STATIONMERGE HEALTHCARE2017-12-29
MERGE EYE STATIONMERGE HEALTHCARE2017-12-29
MERGE EYE STATIONMERGE HEALTHCARE2017-12-29
MERGE EYE STATIONMERGE HEALTHCARE2017-12-14
MERGE EYE STATIONMERGE HEALTHCARE2017-11-21
MERGE EYE STATIONMERGE HEALTHCARE2017-11-17
MERGE EYE STATIONMERGE HEALTHCARE2017-10-15
MERGE EYE STATIONMERGE HEALTHCARE2017-10-07
MERGE EYE STATIONMERGE HEALTHCARE2017-09-27
MERGE EYE STATIONMERGE HEALTHCARE2017-08-06
MERGE EYE STATION2017-07-19
MERGE EYE STATIONMERGE HEALTHCARE2017-07-09
MERGE EYE STATIONMERGE HEALTHCARE2017-06-04
MERGE EYE STATIONMERGE HEALTHCARE2017-03-11
MERGE EYE STATIONMERGE HEALTHCARE2017-03-11
MERGE EYE STATIONMERGE HEALTHCARE2017-03-09
MERGE EYE STATIONMERGE HEALTHCARE2017-03-04
MERGE EYE STATIONMERGE HEALTHCARE2017-02-09
MERGE EYE STATIONMERGE HEALTHCARE2017-01-15
MERGE EYE STATIONMERGE HEALTHCARE2017-01-15
MERGE EYE STATIONMERGE HEALTHCARE2016-12-29
MERGE EYE STATIONMERGE HEALTHCARE2016-12-15
MERGE EYE STATIONMERGE HEALTHCARE2016-11-23
MERGE EYE STATIONMERGE HEALTHCARE2016-11-12
MERGE EYE STATIONMERGE HEALTHCARE2016-11-09
MERGE EYE STATIONMERGE HEALTHCARE2016-11-03
MERGE EYE STATIONMERGE HEALTCHARE2016-10-30
MERGE EYE STATIONMERGE HEALTHCARE2016-10-26
MERGE EYE STATIONMERGE HEALTHCARE2016-10-19
MERGE EYE STATIONMERGE HEALTHCARE2016-10-19
MERGE EYE STATIONMERGE HEALTHCARE2016-09-25
MERGE EYE STATIONMERGE HEALTHCARE2016-09-21
MERGE EYE STATIONMERGE HEALTHCARE2016-09-20
MERGE EYE STATIONMERGE HEALTHCARE2016-09-18
MERGE EYE STATIONMERGE HEALTHCARE2016-09-06
MERGE EYE STATIONMERGE HEALTHCARE2016-09-06
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