Heidelberg Engineering - FDA 510(k) Cleared Devices
Recent clearances: SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA, HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT, HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Heidelberg Engineering Ophthalmic ✕
9 devices
Cleared
Oct 01, 2010
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA,...
Ophthalmic
151d
Cleared
Oct 31, 2006
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
Ophthalmic
11d
Cleared
Jan 13, 2006
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
Ophthalmic
86d
Cleared
Oct 13, 2004
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
Ophthalmic
9d
Cleared
Jul 29, 1997
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
Ophthalmic
83d
Cleared
Nov 14, 1994
RETINA FLOWMETER
Ophthalmic
91d
Cleared
Nov 14, 1994
RETINA TOMOGRAPH AND FLOWMETER
Ophthalmic
91d
Cleared
Nov 14, 1994
RETINA ANGIOGRAPH
Ophthalmic
74d
Cleared
Sep 27, 1991
HEIDELBERG RETINA TOMOGRAPH
Ophthalmic
88d