Oehm Und Rehbein GmbH: FDA clearances and approvals
Oehm Und Rehbein GmbH has 5 FDA 510(k) clearances (first 2007, latest 2018), across 3 product codes in 1 review panel. Median 510(k) review time: 88 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 190 |
| 2014 | 1 | 88 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 28 |
| 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, Oehm Und Rehbein GmbH's cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
Review panels
- Radiology (5)
Most recent Oehm Und Rehbein GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182317 | AMADEO M-DR mini, AMADEO M-AX mini | IZL | 2018-09-24 | 28 |
| K141440 | DICOMPACS DX-R WITH FLAT PANEL | MQB | 2014-08-29 | 88 |
| K131211 | DICOMPACS DX-R WITH FLAT PANEL | MQB | 2013-11-05 | 190 |
| K091364 | DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 | LLZ | 2009-12-11 | 217 |
| K070618 | DICOMPACS, MODEL 5 | LLZ | 2007-04-25 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Oehm Und Rehbein GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Oehm Und Rehbein GmbH have?
Oehm Und Rehbein GmbH has 5 FDA 510(k) clearances (first 2007, latest 2018), across 3 product codes in 1 review panel.
How long does FDA take to clear Oehm Und Rehbein GmbH's 510(k)s?
The median time from FDA receipt to decision across Oehm Und Rehbein GmbH's cleared 510(k)s is 88 days.
What devices does Oehm Und Rehbein GmbH make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 2); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); IZL (System, X-Ray, Mobile, 1).
Has Oehm Und Rehbein GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Oehm Und Rehbein GmbH. Related entities may recall under other names.
Next steps
- See all 5 Oehm Und Rehbein GmbH clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Oehm Und Rehbein GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.