Atlas FDA

HKI

157 FDA 510(k) clearances · Product code

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PANORET, MODEL PNM 60 (K040325)Medibell Medical Vision Technologies , Ltd.2004-03-08
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI (K031629)Canon USA, Inc.2003-06-06
MP-1 MICRO PERIMETER (K023719)Nidek Technologies Srl2002-12-23
FUNDUS AUTOIMAGER (K020888)Visual Pathways, Inc.2002-11-07
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM (K022164)Zeta Development Laboratories2002-07-26
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 (K014274)Nidek, Inc.2002-04-17
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM (K011877)Carl Zeiss Jena GmbH2001-09-26
ISCREEN VISION SCREENER (K010315)Iscreen, LLC2001-06-01
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II (K002920)Escalon Medical Corp.2000-12-18
RETINADX (K003236)Regulatory Associates, Inc.2000-11-02
RETCAM II (K001275)Massie Research Laboratories, Inc.2000-07-13
EYECAP IMAGING SYSTEM (K000368)Clement Clarke Intl., Ltd.2000-05-04
DIGISCOPE OPHTHALMIC CAMERA (K990205)Eye Tel Imaging, Inc.1999-03-26
WINSTATION RETINAL IMAGER (K982689)Ophthalmic Imaging Systems1998-10-23
DISCAM DIGITAL IMAGING SYSTEM (K974535)Marcher Enterprises, Ltd.1998-08-14
OPHTHAVISION IMAGING SYSTEM (K980295)Mrp Group, Inc.1998-05-19
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM (K980246)Canon USA, Inc.1998-05-06
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER (K980357)Konan, Inc.1998-04-24
RETINAL CUBE (K973950)Applied Spectral Imaging , Ltd.1997-12-12
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) (K973533)Nidek, Inc.1997-11-04
NIDEK HANDY (K973218)Nidek, Inc.1997-11-04
CATARACTSCREENER CT - S (K972440)Neitz Instruments Company, Ltd.1997-09-30
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM (K971685)Tomey Corporation USA1997-06-24
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) (K963333)Karl Storz Imaging, Inc.1996-10-22
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM (K955442)Kowa Optimed, Inc.1996-01-03
KOWA GENESIS HAND-HELD FUNDUS CAMERA (K954781)Kowa Optimed, Inc.1995-12-01
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C (K954780)Kowa Optimed, Inc.1995-12-01
ANGIOVISION 1000 (K953973)Medivision Medical Imaging, Ltd.1995-11-17
ANGIOVISION VIEWING STATION (K953972)Medivision Medical Imaging, Ltd.1995-11-17
ORIMS DIGITAL ANGIOGRAPHY SYSTEM (K952480)Midwest Ophthalmic Instruments, Inc.1995-08-25
NON-MYDRIATIC RETINAL CAMERA (K941234)Canon USA, Inc.1995-06-07
KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 (K950091)Konan Medical, Inc.1995-03-01
60 FUNDUS CAMERA CF-60UV (K946058)Canon USA, Inc.1995-02-03
60 DEGREE FUNDUS CAMERA, CF-60UD (K934663)Canon USA, Inc.1994-02-22
MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS (K930442)Marco Ophthalmic, Inc.1993-08-09
LEMPERT OPTIC DISC ANALYSIS SYSTEM (K923708)Lempert Ophthalmic Instruments1993-03-19
CHROMOS IMAGER (K923958)Chromos Imaging, Inc.1993-03-04
CANDELA RETINAL CAMERA (K913314)Candela Laser Corp.1992-01-23
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM (K913929)Ophthalmic Imaging Systems1991-11-27
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF (K911439)Canon USA, Inc.1991-06-17
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL (K895474)Canon USA, Inc.1989-10-04
NEVISCAN MODEL N - 100 (K884989)Special Products, Inc.1989-02-28
OPACITY LENSMETER 701 (K874355)Intraoptics, Inc.1988-01-26
MODIFIED RETINAL CAMERA MODEL CR4-45NM (K874017)Canon USA, Inc.1987-11-02
OXFORD RETRO-ILLUMINATION CATARACT CAMERA (K873157)Holofax , Ltd.1987-09-30
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM (K862323)Canon USA, Inc.1986-08-21
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM (K855170)Canon USA, Inc.1986-02-27
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM (K854330)Par Technology Park1985-12-13
HUMPHREY IMAGE ANALYZER MODEL 110 (K852638)Zeiss Humphrey System1985-08-12
GRC-WT, GRC-W (K843899)Olympus Corp.1985-01-28
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM (K844898)Canon USA, Inc.1985-01-22
CANON 60 FUNDUS CAMERA CF-60U (K843021)Canon USA, Inc.1984-10-05
TEXAS BIO SCAN (K833694)Texas Bio Scan1984-03-02
AO DOCUSTAR(MMIRO) FUNDUS CAMERA (K822991)Warner-Lambert Co.1983-02-24
AML (ANGLE MAGNIFYING LENS (K823719)Nikon, Inc.1983-01-05
COHERENT FUNDUSL RETINAL CAMERA (K822908)Coherent Medical Division1983-01-05
POMERANTZEFF EQUATOR PLUS CAMERA (K770888)Medical Instrument Research Assoc., Inc.1977-06-03
← Previous

Track HKI automatically

Every clearance here is in the API, with alerts when new ones post.