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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

DeviceProduct codeClassRoleSource
Adaptor, Holder, SyringeIQG1Repackager or relabeleraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Repackager or relabeleraccessdata.fda.gov
Applicator, VaginalHGD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bag, IceKYR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Bandage, ElasticFQM1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Repackager or relabeler, Specification developeraccessdata.fda.gov
Case, Contact LensLRX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Container, SharpsMMK2Complaint file establishmentaccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeleraccessdata.fda.gov
Cover, CastKIA1Repackager or relabeleraccessdata.fda.gov
Cup, EyeLXQURepackager or relabeler, Specification developeraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Detectors And Removers, Lice, (Including Combs)LJL1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Device, AcupressureMVVURepackager or relabeler, Specification developeraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Dispenser, Solid MedicationNXB1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Douche Apparatus, Vaginal, TherapeuticHED1Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Dropper, EntKCM1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Repackager or relabeleraccessdata.fda.gov
Ear Irrigation KitOGQ1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Enema KitFCE1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKRNComplaint file establishment, Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Joint, Ankle, External BraceITW1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Mask, SurgicalFXX2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Orthosis, LumbarIQE1Repackager or relabeleraccessdata.fda.gov
OtoscopeERA1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Repackager or relabeler, Specification developeraccessdata.fda.gov
Pill Crusher/CutterOHY1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Protector, Hearing (Insert)EWDUComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Reminder, MedicationNXQ1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Respirator, SurgicalMSH2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Ring, Teething, Non-Fluid FilledMEF1Repackager or relabeleraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Specification developeraccessdata.fda.gov
Speculum, EntEPY1Repackager or relabeleraccessdata.fda.gov
Speculum, IlluminatedFXF1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Splint, Temporary TrainingIQM1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Spoon, EarJZE1Repackager or relabeleraccessdata.fda.gov
Strip, Temperature, Forehead, Liquid CrystalKPD2Repackager or relabeleraccessdata.fda.gov
Syringe, EntKCP1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeler, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 9, 2014K140409FLENTS PLASTIC EYE WASH CUPLXQSubstantially EquivalentApothecary Products, Inc.accessdata.fda.gov
July 14, 2011K111856SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASELRXSubstantially EquivalentApothecary Products, Inc.accessdata.fda.gov
December 15, 2008K083129SHARPS COMPLIANCE CONTAINERMMKSubstantially EquivalentSharps Compliance, Inc.accessdata.fda.gov
November 26, 2004K041766EZY-TRAVEL WRISTBANDMVVSubstantially EquivalentApothecary Products, Inc.accessdata.fda.gov
October 8, 2004K041877ACU-STRAP MOTION SICKNESS BANDMVVSubstantially EquivalentHealth Ent., Inc.accessdata.fda.gov
July 23, 2002K020474MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95MSHSubstantially EquivalentMakrite Industries, Inc.accessdata.fda.gov
November 3, 1989K895077SURGICAL MASK/DENTAL MASKFXXSubstantially EquivalentAshton Medical Products, Inc.accessdata.fda.gov
May 4, 1987K871403MODIFIED C.P.R. MICROSHIELDCAESubstantially EquivalentWestmark Enterprises, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 30, 202392247Class IIOngoingEye and Ear Dropper, Product Code 67082Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.accessdata.fda.gov

Compare with other makers

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.