HLI

Product Code: HLI


Products Classified as HLI

4190Ophthalmoscope, Ac-poweredOphthalmoscope.

Total Product Life Cycle (TPLC) Devices

4190Ophthalmoscope, Ac-poweredOphthalmoscope.

FDA Consensus Standards

Ophthalmoscope, Ac-Powered [29877]21 CFR §886.1570 🔎
Ophthalmoscope, Ac-Powered [29874]21 CFR §886.1570 🔎
Ophthalmoscope, Ac-Powered [34468]21 CFR §886.1570 🔎

Pre-market Notifications for HLI

K153080RTVue XR OCT Avanti With AngioVue SoftwareOPTOVUE, INC.
K150722EnFocus 2300, EnFocus 4400BIOPTIGEN, INC.
K142953OCT-CameraOptoMedical Technologies GmbH
K141638PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPEPROPPER MANUFACTURING CO.,INC.
K133892IVUE 500OPTOVUE, INC.
K133758CENTERVUE MACULAR INTEGRITY ASSESSMENTCENTERVUE SPA
K131939AMICO DH-W35 OPHTHALMOSCOPE SERIESAMICO DIAGNOSTIC INCORPORATED
K123316HEINE OMEGA 500HEINE OPTOTECHNIK GMBH & CO. KG.
K121739IVUE WITH NORMATIVE DATABASEOPTOVUE, INC.
K120238RTVUE XR OCTOPTOVUE, INC.
K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)BIOPTIGEN, INC.
K111531RHA2020ANNIDIS HEALTH SYSTEMS CORP.
K110205AAIO-7, AAIO WIRLESSAPPASAMY ASSOCIATES
K103266ISTANDOPTOVUE, INC.
K101505RTVUE MODEL RTVUE 100OPTOVUE, INC.

Global Unique Device Identification Database

00697077002459Ophthalmoscope, Ac-Powered
00697077002435Ophthalmoscope, Ac-Powered
00697077002411Ophthalmoscope, Ac-Powered
00697077002329Ophthalmoscope, Ac-Powered
00697077002299Ophthalmoscope, Ac-Powered
00697077002275Ophthalmoscope, Ac-Powered
00697077002268Ophthalmoscope, Ac-Powered
00697077002107Ophthalmoscope, Ac-Powered
00697077002053Ophthalmoscope, Ac-Powered
00697077001773Ophthalmoscope, Ac-Powered
00697077001766Ophthalmoscope, Ac-Powered
00697077001759Ophthalmoscope, Ac-Powered
00697077001742Ophthalmoscope, Ac-Powered
00697077001735Ophthalmoscope, Ac-Powered
00697077001728Ophthalmoscope, Ac-Powered

Maude Adverse Events

WELCH ALLYN, INCCOVIDIEN IRELAND MFG TULLAMORE2018-10-19
CIRRUS HD OCTCARL ZEISS MEDITEC, INC.2013-06-25
PANORAMIC 200 OPHTHALMOSCOPEOPTOS PLC2009-06-11
STRATUS OCT PATIENT MODEL DCARL ZEISS MEDITEC.2008-10-22
VISANTECARL ZEISS MEDITEC INC2006-09-21
STRATUS OCTCARL ZEISS MEDITEC, INC.2006-03-13
STANDARD OPHTHALMOSCOPEWELCH ALLYN, INC.2005-07-22
STRATUSOCTCARL ZEISS MEDITEC INC2005-06-03
STRATUSOCTCARL ZEISS MEDITEC INC2005-03-18
STRATUSOCTCARL ZEISS MEDITEC INC2005-03-18
STRATUS OCT.CARL ZEISS MEDITEC INC2004-06-01
STRATUS OCTCARL ZEISS MEDITEC INC2004-02-26
STRATUS OCTCARL ZEISS MEDITEC INC.2004-02-06
HGMINDIRECT OPHTHALMOSCOPEFISMA2001-09-17
HGMINDIRECT OPHTALMOSCOPE ATTACHMENTFISMA2001-08-15
HGMINDIRECT OPHTHALMOSCOPEFISMA2001-07-18
HGMINDIRECT OPHTHALMOSCOPEFISMA2001-05-29
HGMLASER INDIRECT OPHTHALMOSCOPEFISMA, INC.1998-01-12
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