Oehm Und Rehbein GmbH

FDA Regulatory Profile

Oehm Und Rehbein GmbH has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 17, 2019 · NAI
Latest 510(k)
Sep 24, 2018

Reviewing Oehm Und Rehbein GmbH as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Oehm Und Rehbein GmbH's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 17, 2019Rostock, GermanyDevicesNo Action Indicated (NAI)3006542593

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K182317AMADEO M-DR mini, AMADEO M-AX miniSep 24, 2018
K141440DICOMPACS DX-R WITH FLAT PANELAug 29, 2014
K131211DICOMPACS DX-R WITH FLAT PANELNov 5, 2013
K091364DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4Dec 11, 2009
K070618DICOMPACS, MODEL 5Apr 25, 2007