Heine Optotechnik GmbH & Co. KG is one of 387 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Heine Optotechnik GmbH & Co. KG - FDA 510(k) Cleared Devices
Recent clearances: HEINE BETA 200, HEINE BETA 200 S, HEINE K 180, HEINE SIGMA 250 & HEINE SIGMA 250 M2, HEINE MINI 3000(R) OPHTHALMOSCOPE
7
Total
7
Cleared
0
Denied
Heine Optotechnik GmbH & Co. KG has 7 FDA 510(k) cleared medical devices. Based in Hamburg, DE.
Historical record: 7 cleared submissions from 2010 to 2015. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Heine Optotechnik GmbH & Co. KG Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Tuv Sud America, Inc. and Heine USA , Ltd..
FDA 510(k) Regulatory Record - Heine Optotechnik GmbH & Co. KG
7 devices
Cleared
May 18, 2015
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
Ophthalmic
256d
Cleared
Jan 29, 2015
HEINE SIGMA 250 & HEINE SIGMA 250 M2
Ophthalmic
121d
Cleared
Mar 07, 2014
HEINE MINI 3000(R) OPHTHALMOSCOPE
Ophthalmic
253d
Cleared
Dec 04, 2013
HEINE BETA 200(R) OPHTHALMOSCOPE
Ophthalmic
160d
Cleared
Mar 22, 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
Ophthalmic
121d
Cleared
Feb 26, 2013
HEINE OMEGA 500
Ophthalmic
124d
Cleared
Aug 27, 2010
HEINE GAMMA G7
Cardiovascular
51d