Data / Medical devices / United States / Hudson Scientific LLC
Hudson Scientific LLC: FDA-registered device maker in Hudson, MI, United States, 6 510(k) clearances
Hudson Scientific LLC is registered with the FDA (registration 3013037032) in Hudson, MI, United States. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 18, 2017. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013037032
- Address
- 103 W Main ST, Hudson, MI, United States, 49247
- Owner or operator
- Hudson Scientific LLC (10053280)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 2, 2017
- Registered through
- 2026
- Brand names listed
- Alzair Allergy Blocker, Breathe Ease, City Med Rx Powder Free Nitrile Examination Gloves, EZbra Breast Dressing, Nuvazil Silicone Gel Scar Dressings, OSSIX BONE, OSSIX PLUS, OSSIX VOLUMAX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | NUP | 2 | Specification developer | accessdata.fda.gov |
| Device, Galvanic Skin Response Measurement | GZO | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holding Chambers, Direct Patient Interface | NVP | 2 | Complaint file establishment | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2017 | K163714 | OSSIX BONE | NPM | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| June 14, 2017 | K170848 | Alzair Allergy Blocker | NUP | Substantially Equivalent | Nasaleze International, Ltd. | accessdata.fda.gov |
| August 4, 2016 | K160281 | OSSIX PLUS | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| August 4, 2016 | K153549 | OSSIX VOLUMAX | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| August 3, 2016 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| January 26, 2016 | K143615 | Antistatic Compact Space Chamber | NVP | Substantially Equivalent | Medical Developments International Limited | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 2, 2018 | 80483 | Class II | Terminated | 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 supplement | 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. | accessdata.fda.gov |
| October 19, 2016 | 75055 | Class II | Terminated | 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) | accessdata.fda.gov |
Compare with other makers
- All makers of Holding Chambers, Direct Patient Interface
- All makers of Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Bone Grafting Material, Animal Source
- All makers of Device, Galvanic Skin Response Measurement
- All makers of Medical Glove, Specialty
Updated July 18, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.