Hudson Scientific LLC
Hudson, MI, US
HUDSON SCIENTIFIC LLC appears in FDA device records in Hudson, MI. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Hudson Scientific LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ultroid Technologies, Inc.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013037032 | 3013037032 | HUDSON SCIENTIFIC LLC | 103 W MAIN ST, Hudson, MI 49247 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NPLBarrier, Animal Source, Intraoral
- NPMBone Grafting Material, Animal Source
- NUPCream, Nasal, Topical, Mechanical Allergen Particle Barrier
- GZODevice, Galvanic Skin Response Measurement
- MHWDressing, Compression
- MDAElastomer, Silicone, For Scar Management
- NVPHolding Chambers, Direct Patient Interface
- LZCMedical Glove, Specialty
- LZAPolymer Patient Examination Glove
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2736-2018 | iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements. | The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device. | Class II | Terminated | |
| Z-0785-2017 | Ultroid Sterile Disposable Probes sold individually | Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation) | Class II | Terminated | |
| Z-0784-2017 | Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes. | Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation) | Class II | Terminated | |
| Z-0783-2017 | Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes | Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation) | Class II | Terminated | |
| Z-0782-2017 | Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes | Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation) | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain