Company ยท DE
Heine Optotechnik GmbH & Co. KG
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2015. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2015 | K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Jan 29, 2015 | K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Mar 7, 2014 | K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Dec 4, 2013 | K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Mar 22, 2013 | K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE Heine Optotechnik GmbH & Co. KG, DE | HLJ |
| Feb 26, 2013 | K123316 | HEINE OMEGA 500 Heine Optotechnik GmbH & Co. KG, DE | HLI |
| Aug 27, 2010 | K101892 | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- Heine Optotechnik GmbH & Co. KG, DE | DXQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||