Data / Medical devices / United States / Apothecary Products, LLC.
Apothecary Products, LLC.: FDA-registered device maker in Burnsville, MN, United States, 8 510(k) clearances
Apothecary Products, LLC. is registered with the FDA (registration 2183416) in Burnsville, MN, United States. It lists 46 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 9, 2014. 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
- 2183416
- Address
- 11750 12th Ave S, Burnsville, MN, United States, 55337
- Owner or operator
- APOTHECARY PRODUCTS, LLC (2183416)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 23, 1991
- Registered through
- 2026
- Brand names listed
- 1 CC Droppper: 31881, 10 ml Medicine Syringe: 230B, 230B1, 10ml Oral Syringe: 77503, 77516, 67007, 67007A, 67007BC, 84840, 67007CA, 67007AMZ1, 10ml Spoon: 67145BC, 1ml Oral Syringe: 77500, 1ml Straight Tip Glass Dropper: 67024, 69349, 67024AMZ, 67024AZ, 69349CA, 1ml bent & Straight Tip Glass Dropper: 67082, K508, 2-WEEK DUETS PILL PLANNER: 67596BLG,67596PY,67596BLP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Applicator, Vaginal | HGD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Case, Contact Lens | LRX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Container, Sharps | MMK | 2 | Complaint file establishment | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cover, Cast | KIA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cup, Eye | LXQ | U | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Manufacturer | accessdata.fda.gov |
| Detectors And Removers, Lice, (Including Combs) | LJL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Device, Acupressure | MVV | U | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Douche Apparatus, Vaginal, Therapeutic | HED | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dropper, Ent | KCM | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ear Irrigation Kit | OGQ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Otoscope | ERA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pill Crusher/Cutter | OHY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Protector, Hearing (Insert) | EWD | U | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Specification developer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Illuminated | FXF | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Splint, Temporary Training | IQM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Spoon, Ear | JZE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Repackager or relabeler, 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 9, 2014 | K140409 | FLENTS PLASTIC EYE WASH CUP | LXQ | Substantially Equivalent | Apothecary Products, Inc. | accessdata.fda.gov |
| July 14, 2011 | K111856 | SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE | LRX | Substantially Equivalent | Apothecary Products, Inc. | accessdata.fda.gov |
| December 15, 2008 | K083129 | SHARPS COMPLIANCE CONTAINER | MMK | Substantially Equivalent | Sharps Compliance, Inc. | accessdata.fda.gov |
| November 26, 2004 | K041766 | EZY-TRAVEL WRISTBAND | MVV | Substantially Equivalent | Apothecary Products, Inc. | accessdata.fda.gov |
| October 8, 2004 | K041877 | ACU-STRAP MOTION SICKNESS BAND | MVV | Substantially Equivalent | Health Ent., Inc. | accessdata.fda.gov |
| July 23, 2002 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| November 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | Substantially Equivalent | Ashton Medical Products, Inc. | accessdata.fda.gov |
| May 4, 1987 | K871403 | MODIFIED C.P.R. MICROSHIELD | CAE | Substantially Equivalent | Westmark Enterprises, 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 |
|---|---|---|---|---|---|---|
| March 30, 2023 | 92247 | Class II | Ongoing | Eye and Ear Dropper, Product Code 67082 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Detectors And Removers, Lice, (Including Combs)
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Splint, Temporary Training
- All makers of Curette
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated June 9, 2023. 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.