Merz North America, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Merz North America, Inc.” (first 2017, latest 2017), plus 6 PMA decisions, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 84 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 |
|---|---|---|
| 2017 | 1 | 84 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Merz North America, Inc. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 84 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | 5 | 0 |
| LNM | Agent, Bulking, Injectable For Gastro-Urology Use | 1 | 0 |
| PKO | Transparent Patch For Use In Treatment Of Tattoos | 1 | 1 |
Review panels
Most recent Merz North America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172689 | DESCRIBE PFD Patch | PKO | 2017-11-29 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250016 | PMA | Belotero® Intense (+) Lidocaine | 2026-07-09 |
| P250020 | PMA | Belotero Volume (+) Lidocaine | 2026-05-19 |
| P090016 | PMA | BELOTERO BALANCE | 2011-11-14 |
| P050037 | PMA | RADIESSE 1.3CC AND 0.3CC | 2006-12-22 |
| P050052 | PMA | RADIESSE INJECTABLE IMPLANT | 2006-12-22 |
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2020-09-30.
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 Merz North America, Inc. is the lead sponsor of 30 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07086248: A Study to Determine if RADIESSE® Dilute Treatment in Décolleté of Adult Women Affects Radiographic Imaging Assessments (Active not recruiting, started 2025-07-22)
- NCT06093815: Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products (Completed, started 2023-09-08)
- NCT05163353: Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles (Completed, started 2021-12-10)
- NCT04886232: A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of VP1 Lido US for Volume Augmentation of the Cheek (Completed, started 2021-05-25)
- NCT05067504: Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck (Completed, started 2021-05-24)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Merz North America, Inc. (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Merz Dental GmbH (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Merz North America, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Merz North America, Inc.” (first 2017, latest 2017), plus 6 PMA decisions, across 3 product codes in 2 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 Merz North America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merz North America, Inc. is 84 days.
Which FDA product codes appear under Merz North America, Inc.?
The most frequent FDA product codes under this applicant name are LMH (Implant, Dermal, For Aesthetic Use, 5); LNM (Agent, Bulking, Injectable For Gastro-Urology Use, 1); PKO (Transparent Patch For Use In Treatment Of Tattoos, 1).
Next steps
- See all 1 Merz North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMH, Merz North America, 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.