Q-Med AB: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Q-Med AB”, plus 4 PMA decisions, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | 4 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P140029 | PMA | Restylane Refyne, Restylane Defyne | 2016-12-09 |
| P040024 | PMA | RESTYLANE INJECTABLE GEL | 2005-03-25 |
| P030050 | PMA | SCULPTRA AND SCULPTRA AESTHETIC | 2004-08-03 |
| P020023 | PMA | RESTYLANE INJECTABLE GEL | 2003-12-12 |
Recalls
openFDA lists no recalls under a recalling firm named Q-Med AB.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Q-Med AB (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via LMH)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via LMH)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via LMH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Q-Med AB?
FDA lists 0 510(k) clearances under the applicant name “Q-Med AB”, plus 4 PMA decisions, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Q-Med AB?
The most frequent FDA product codes under this applicant name are LMH (Implant, Dermal, For Aesthetic Use, 4).
Next steps
- See all 0 Q-Med AB clearances with predicates and recalls
- Run predicate analysis for product code LMH, Q-Med AB'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.