Medical Device Manufacturer · US , Carlsbad , CA

Heidelberg Engineering - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1991

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)

View 9 510(k) Devices ↓

Total

Cleared

Denied

Heidelberg Engineering has 9 FDA 510(k) cleared medical devices. Based in Carlsbad, US.

Historical record: 9 cleared submissions from 1991 to 2010. Primary specialty: Ophthalmic.

Browse the FDA 510(k) cleared devices submitted by Heidelberg Engineering Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Underwriters Laboratories, Inc. and Tuv America, Inc..

Heidelberg Engineering is one of 21665 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Heidelberg Engineering

9 devices

1-9 of 9

Cleared Oct 01, 2010

SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA,...

K101223 · OBO

Ophthalmic · 151d

Cleared Oct 31, 2006

HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT

K063191 · OBO

Ophthalmic · 11d

Cleared Jan 13, 2006

HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)

K052935 · MXK

Ophthalmic · 86d

Cleared Oct 13, 2004

HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)

K042742 · MXK

Ophthalmic · 9d

Cleared Jul 29, 1997

HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)

RETINA TOMOGRAPH AND FLOWMETER

HEIDELBERG RETINA TOMOGRAPH

K912891 · HLI

Ophthalmic · 88d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 07, 2026

Heidelberg Engineering - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Heidelberg Engineering

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