Data / Medical devices / United States / MicroCare Medical
MicroCare Medical: FDA-registered device maker in Commerce City, CO, United States, 5 510(k) clearances
MicroCare Medical is registered with the FDA (registration 1720499) in Commerce City, CO, United States. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 7, 2006. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1720499
- Address
- 6120 E. 58TH Ave., Commerce City, CO, United States, 80022
- Owner or operator
- MicroCare, LLC (10082240)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 30, 2021
- Registered through
- 2026
- Brand names listed
- Bi-Arrest, Good Vibrations, Maxitab Gen Purpose Ultrasonic, Multi-Enzymatic Detergent Super Concentrate, Omni II Concentrate Surface Disinfectant, Optizyme, Plaster & Stone Remover, Powerzyme and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Manufacturer | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Manufacturer | accessdata.fda.gov |
| Detergent | JCB | 1 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 7, 2006 | K060103 | ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| December 28, 2005 | K052725 | PROTECTOR NEEDLE SHEATH PROP | FMI | Substantially Equivalent | Certol International, LLC | accessdata.fda.gov |
| May 18, 1998 | K970726 | VAPOCIDE | MED | Substantially Equivalent | Cottrell, Ltd. | accessdata.fda.gov |
| November 9, 1995 | K953829 | SAFE-T-SEAL | KCT | Substantially Equivalent | Gs Medical Packaging, Inc. | accessdata.fda.gov |
| February 14, 1989 | K890128 | FACELOCK FILTER MASK | FXX | Substantially Equivalent | Alpha Protech, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 29, 2024 | 95172 | Class II | Ongoing | Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVU | Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling conta | accessdata.fda.gov |
Compare with other makers
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Sterilant, Medical Devices
- All makers of Needle, Hypodermic, Single Lumen
Updated September 23, 2024. 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.