Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Asahi KaseiLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zoll Manufacturing with 3 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 19, 2019: ZOLL Arrhythmia Management Sysyem.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 19, 2019 | ZOLL Arrhythmia Management SysyemK190939 · MHX | 510(k) clearances |
| Jan 28, 2019 | ZOLL ECG Analysis SoftwareK182093 · DPS | 510(k) clearances |
| May 11, 2018 | µCor Heart Failure and Arrhythmia Management SystemK172510 · MHX | 510(k) clearances |
| Sep 12, 2017 | LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age andClass II · Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock fail | Device recalls |
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
