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.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list TZ Medical with 16 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Oct 29, 2026: TZ Medical Birthing Balloon Kit.
510(k) clearances: 16
Device recalls: 4
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
12017Records1
120182018Records1vs 2017+0
02019Records0vs 2018−1
020202020Records0vs 2019+0
02021Records0vs 2020+0
020222022Records0vs 2021+0
02023Records0vs 2022+0
020242024Records0vs 2023+0
02025Records0vs 2024+0
220262026 to dateRecords2
Latest Records
Newest first across sources; each opens the record
Tz Medical, Inc.TZ Medical Inc.TZ MedicalTZ Medical, Inc.
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