Apothecary Products, LLC
Burnsville, MN, US
APOTHECARY PRODUCTS, LLC. appears in FDA device records in Burnsville, MN. FDA records list 6 510(k) clearances between and , 2 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Apothecary Products, LLC between 1984 and 2014. The busiest year on record is 1984, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1989 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140409 | FLENTS PLASTIC EYE WASH CUP | LXQ | Substantially Equivalent | |
| K111856 | SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE | LRX | Substantially Equivalent | |
| K041766 | EZY-TRAVEL WRISTBAND | MVV | Substantially Equivalent | |
| K020296 | ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 | EWD | Substantially Equivalent | |
| K892242 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | |
| K833311 | NITROGLYCERINE CONTAINER | NXB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183416 | 2183416 | APOTHECARY PRODUCTS, LLC. | 11750 12th Ave S, BURNSVILLE, MN 55337 US | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPNAccessories, Soft Lens Products
- IQGAdaptor, Holder, Syringe
- CAEAirway, Oropharyngeal, Anesthesiology
- HGDApplicator, Vaginal
- KYRBag, Ice
- FQMBandage, Elastic
- FPFBottle, Hot/Cold Water
- LRXCase, Contact Lens
- MMKContainer, Sharps
- FMHContainer, Specimen, Sterile
- KIACover, Cast
- LXQCup, Eye
- HTFCurette
- LJLDetectors And Removers, Lice, (Including Combs)
- MVVDevice, Acupressure
- KYXDispenser, Liquid Medication
- NXBDispenser, Solid Medication
- HEDDouche Apparatus, Vaginal, Therapeutic
- MHWDressing, Compression
- NADDressing, Wound, Occlusive
- KCMDropper, Ent
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- OGQEar Irrigation Kit
- FCEEnema Kit
- QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- NABGauze / Sponge,Nonresorbable For External Use
- ITWJoint, Ankle, External Brace
- LYYLatex Patient Examination Glove
- FXXMask, Surgical
- IQEOrthosis, Lumbar
- ERAOtoscope
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- OHYPill Crusher/Cutter
- EWDProtector, Hearing (Insert)
- NXQReminder, Medication
- MSHRespirator, Surgical
- MEFRing, Teething, Non-Fluid Filled
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- ILISling, Arm
- EPYSpeculum, Ent
- FXFSpeculum, Illuminated
- ILHSplint, Hand, And Components
- IQMSplint, Temporary Training
- JZESpoon, Ear
- KPDStrip, Temperature, Forehead, Liquid Crystal
- KCPSyringe, Ent
- KYZSyringe, Irrigating (Non Dental)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1703-2023 | Medicine Dropper, Product Code K508 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Open, Classified | |
| Z-1702-2023 | Eye and Ear Dropper, Product Code 67082 | Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain