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BioStom
Forward Science Technologies LLC · Model BioStom 1ct · UDI-DI 00370275850106
10
510(k) clearances
97
Adverse events (20 deaths)
14
Recalls
50
Facilities
Description
BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precise application and will be provided non-sterile and is not intended to be sterilized before use. Because BioStom Oral Pain Gel is to be administered several times per day, it will primarily be used at the home, office, or other non-clinical settings. However, BioStom may also be used in clinical or healthcare facility settings where patients are receiving services
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
| 2015-03-26 | PhotoMedex, Inc. | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearan |
| 2015-02-25 | Amerx Health Care Corp. | Nonapproved labeling claims (Sterile) |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.