Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 5 companies' records, each linked to the record.
As of Nov 13, 2026, FDA's public records list Bruker and its 5 subsidiaries with 30 510(k) clearances, 8 device recalls and 1 AI-enabled device. The most recent is a 510(k) clearance dated Aug 13, 2025: MBT Compass HT CA Software; MBT FAST Shuttle US IVD.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Bruker and its 5 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 13, 2025 | MBT Compass HT CA Software; MBT FAST Shuttle US IVDK251495 · QBN | 510(k) clearances |
| Dec 27, 2020 | MBT SepsityperK193419 · QNJ | 510(k) clearances |
| Nov 15, 2018 | V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180Class II · During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspi | Device recalls |
| Sep 7, 2018 | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, miClass II · The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a | Device recalls |
| Apr 20, 2018 | MALDI Biotyper CA SystemDEN170081 · QBN | 510(k) clearances |
| Jul 26, 2017 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemK163536 · PEX | 510(k) clearances |
| Jan 18, 2016 | V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, miClass II · Instrument stopped working due to a software lockup, and no patient results are produced. | Device recalls |
| Mar 27, 2015 | MALDI Biotyper CA SystemK142677 · PEX | 510(k) clearances |
| Nov 21, 2013 | MALDI BIOTYPER CA (MBT-CA) SYSTEMK130831 · PEX | 510(k) clearances |
| Nov 21, 2013 | MALDI BIOTYPER CA (MBT-CA) SYSTEMK130831 · Microbiology | AI-enabled devices |
| Mar 27, 2013 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICK121823 · JFS | 510(k) clearances |
| Jan 10, 2012 | Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical useClass II · The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no p | Device recalls |
| Jan 10, 2012 | Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical lClass II · The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no p | Device recalls |
| Jan 10, 2012 | V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical useClass II · The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no p | Device recalls |
| Jan 10, 2012 | Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical cheClass II · The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no p | Device recalls |
| Jan 10, 2012 | Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical useClass II · The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no p | Device recalls |
| Nov 1, 2002 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTK022021 · GFO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
