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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.