Pharmaceutical companyLabelled 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 15, 2026, FDA's public records list Otsuka Holdings and its 5 subsidiaries with 47 drug applications, 4 510(k) clearances, 3 drug recalls and 2 device recalls. The most recent is a device recall dated Jan 29, 2026: Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Cath….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Otsuka Holdings and its 5 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 29, 2026 | Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product DesClass II · Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | Device recalls |
| Jan 29, 2026 | Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product DesClass II · Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | Device recalls |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Class I · Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE | Drug recalls |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, IClass I · Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE | Drug recalls |
| Oct 27, 2025 | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37Class II · Lack of Assurance of Sterility: Potential for flexible container leaks. | Drug recalls |
| Sep 30, 1994 | ORACLE MRI WHOLE BODY MR IMAGING SYSTEMK942953 · LNH | 510(k) clearances |
| Sep 21, 1994 | MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1K942776 · LNH | 510(k) clearances |
| Dec 2, 1993 | OE 1.5 SIK925858 · LNH | 510(k) clearances |
| Jul 10, 1992 | MRI OE 1.5 SIK920543 · LNH | 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
