Ceremed , Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Ceremed , Inc.” (first 2004, latest 2016), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 62 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 115 |
| 2013 | 1 | 58 |
| 2014 | 0 | — |
| 2015 | 1 | 279 |
| 2016 | 2 | 111 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 8 | 8 |
| MTJ | Wax, Bone | 6 | 6 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 4 | 4 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
Review panels
- Ear, Nose and Throat (8)
- Orthopedic (6)
- General and Plastic Surgery (4)
- Dental (1)
- Neurology (1)
Most recent Ceremed , Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161446 | Biopor Porous Polyethylene Implants | GWO | 2016-09-27 | 125 |
| K160988 | Biopor, AOC Porous Polyethylene, Cerepor | KKY | 2016-07-14 | 97 |
| K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | KKY | 2015-04-16 | 279 |
| K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | KHJ | 2013-09-12 | 58 |
| K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | KHJ | 2012-11-27 | 97 |
| K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL | KHJ | 2012-06-06 | 133 |
| K103047 | CERETENE SOLUBLE IMPLANT MATERIAL | KHJ | 2011-01-05 | 82 |
| K102071 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | MTJ | 2010-10-08 | 77 |
| K091636 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | MTJ | 2009-06-22 | 18 |
| K082491 | OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE | MTJ | 2008-09-24 | 27 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ceremed , Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ceremed , Inc.?
FDA lists 20 510(k) clearances under the applicant name “Ceremed , Inc.” (first 2004, latest 2016), across 5 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ceremed , Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ceremed , Inc. is 62 days.
Which FDA product codes appear under Ceremed , Inc.?
The most frequent FDA product codes under this applicant name are KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), 8); MTJ (Wax, Bone, 6); KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, 4).
Next steps
- See all 20 Ceremed , Inc. clearances with predicates and recalls
- Run predicate analysis for product code KHJ, Ceremed , Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.