Croma-Pharma GmbH: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Croma-Pharma GmbH”, plus 2 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 | 2 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250021 | PMA | saypha® ChiQ | 2026-06-12 |
| P240008 | PMA | saypha® MagIQ | 2025-09-08 |
Recalls
openFDA lists no recalls under a recalling firm named Croma-Pharma GmbH.
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.
Device clinical trials
An industry sponsor named Croma-Pharma GmbH is the lead sponsor of 16 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07475455: Filler Post Market Survey (FIPS) (Active not recruiting, started 2025-12-22)
- NCT06135337: THIODERM ELATE for Augmentation of Very Thin, Thin, and Moderately Thick Lips (Completed, started 2023-06-01)
- NCT06128109: THIODERM STRONG Compared to Juvéderm® VOLUMA® Lidocaine for the Treatment of Midface Volume Deficit (Completed, started 2023-01-24)
- NCT04883632: Saypha® Volume LIdocaine in Nasolabial Folds (Completed, started 2019-11-05)
- NCT03990883: Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF) (Completed, started 2019-06-04)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Croma-Pharma GmbH (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 Croma-Pharma GmbH?
FDA lists 0 510(k) clearances under the applicant name “Croma-Pharma GmbH”, plus 2 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 Croma-Pharma GmbH?
The most frequent FDA product codes under this applicant name are LMH (Implant, Dermal, For Aesthetic Use, 2).
Next steps
- See all 0 Croma-Pharma GmbH clearances with predicates and recalls
- Run predicate analysis for product code LMH, Croma-Pharma GmbH'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.