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Getinge

Medical device makerAI in ChinaAI. FDA records under 2 spellings of its name, each linked to the record.

  • Records across the group: 1,240, 37 entitiesAI
  • Device recalls: 765
  • 510(k) clearances: 474
  • Warning letters: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Getinge and its 36 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Aug 26, 2026Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)K253715 · PIF510(k) clearances
Apr 27, 2026Fusion Bioline Vascular GraftK252445 · DSY510(k) clearances
Jan 30, 2026BAROguard Donor Lung Preservation SystemK254305 · KDN510(k) clearances
May 30, 2025Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)K251238 · GEI510(k) clearances
Feb 26, 2025Vasoview Hemopro 3 Power SupplyK243918 · GEI510(k) clearances
Oct 23, 2024KIDNEYvault Portable Renal Perfusion SystemK234060 · KDN510(k) clearances
Mar 28, 2024Advanta VXT Vascular Graft, Flixene Vascular GraftK231972 · DSY510(k) clearances
Feb 27, 2024Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)K233879 · GEI510(k) clearances
Feb 6, 2019Warning letter: CAPA, Design controls, 510(k) requiredCDRHWarning letters
Nov 4, 2014Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage:Class II · Internal testing and investigation of the packaging revealed cracks and holes in primary packagingDevice recalls

Subsidiaries and Divisions

36 firms in the Getinge group, most records first

Canada and Imports

Across the Getinge group, matched by company name
Active Health Canada device licences
71, as of Nov 10, 2026
FDA import refusals since 2024
17 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
Getinge (Suzhou) Co., Ltd.Getinge (Suzhou) Co Ltd
FEI numbers in warning letters
3001418283

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

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.