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.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list HealthTronics, Inc. with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Feb 5, 2016: Cryocare CS Surgical System.
| Feb 5, 2016 | Cryocare CS Surgical SystemK153489 · GEH | 510(k) clearances |
| Sep 9, 2015 | Cryocare CS-3 Surgical System version 5K151968 · GEH | 510(k) clearances |
| Jun 25, 2015 | CRYOCARE CS SURGICAL SYSTEMK141110 · GEH | 510(k) clearances |
| Dec 20, 2012 | HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare SClass II · The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration | Device recalls |
| Dec 23, 2002 | LTFS230K021775 · LNS | 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
