Data / Medical devices / United States / Vericel Corporation
Vericel Corporation: FDA-registered device maker in Cambridge, MA, United States, 1 510(k) clearance
Vericel Corporation is registered with the FDA (registration 1226230) in Cambridge, MA, United States. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 7, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226230
- FEI number
- 3002836339
- Address
- 64 Sidney St, Cambridge, MA, United States, 02139
- Owner or operator
- Vericel (10051107)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 4, 2016
- Registered through
- 2026
- Brand names listed
- 12mm x 21mm MACI Cutter, 12mm x 21mm Min Arthroscopic Cutter, 14mm x 26mm MACI Cutter, 14mm x 26mm Max Arthroscopic Cutter, 14mm x 26mm Min Arthroscopic Cutter, 15mm V-Shuttle Delivery Device, 15mm x 3cm Cannula Assembly, 15mm x 4cm Cannula Assembly and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | KDW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cultured Epithelial Autograft | OCE | f | Manufacturer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Passer | HWQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 7, 2018 | K171520 | SteriZign Signatur Device Protection System | KCT | Substantially Equivalent | Sterizign Precision Technologies, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 13, 2010 | 56218 | Not yet classified | Terminated | Genzyme Biosurgery Essentials Kit, Item Number 82004 | Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Instrument, Surgical, Disposable
- All makers of Cutter, Surgical
- All makers of Media And Components, Synthetic Cell And Tissue Culture
Updated February 7, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.