HealthTronics, LLC
United Statesfrom the FDA registration address FDA establishment FEI 3005655081
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 2
Catalogue
Cryocare CS Surgical System Ref K153489
Regimes: 510(k) Registry: 510(k)Cryocare CS-3 Surgical System version 5 Ref K151968
Regimes: 510(k) Registry: 510(k)Cryocare Cs Surgical System Ref K141110
Regimes: 510(k) Registry: 510(k)LTFS230 Ref K021775
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3005655081
- Address
- 1990 Steam Way, Round Rock, TX, 78665
FDA recalls
2012
- 20 Dec 2012 Z-0825-2013 Class II Terminated The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
- 27 Feb 2012 Z-1275-2012 Not yet classified Terminated HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area believed to be under surveillance.
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Frequently asked questions
How many devices does HealthTronics, LLC have in the registry?
The registry currently lists 4 devices for HealthTronics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list HealthTronics, LLC's devices?
Among its 4 most recently registered devices, HealthTronics, LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do HealthTronics, LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for HealthTronics, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for HealthTronics, LLC?
FDA recall records list 2 recalls initiated by HealthTronics, LLC, the most recent initiated on 20 Dec 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from HealthTronics, LLC in the registry?
The most recently registered devices listed for HealthTronics, LLC include Cryocare CS Surgical System, Cryocare CS-3 Surgical System version 5 and LTFS230.