Company ยท KR
Huvitz Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(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 |
|---|---|---|---|
| Oct 23, 2023 | K232143 | Applanation Tonometer HT-5000 Huvitz Co., Ltd., KR | HKY |
| Feb 2, 2021 | K202097 | Fundus Camera Huvitz Co., Ltd., KR | HKI |
| Jul 18, 2019 | K191615 | Huvitz Imaging System Huvitz Co., Ltd., KR | NFJ |
| Apr 6, 2017 | K161829 | Huvitz Imaging System Huvitz Co., Ltd., KR | NFJ |
| Dec 3, 2009 | K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 Huvitz Co., Ltd. | HJO |
| Jan 11, 2008 | K073190 | SLIT LAMP Huvitz Co., Ltd. | HJO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||