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Data / Medical devices / United States / Shoney Scientific, Inc.

Shoney Scientific, Inc.: FDA-registered device maker in Waukesha, WI, United States, 7 510(k) clearances

Shoney Scientific, Inc. is registered with the FDA (registration 2183650) in Waukesha, WI, United States. It lists 39 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 4, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Shoney Scientific, Inc.
FDA registration number
2183650
Address
West 223 North 720 Saratoga DR., Suite 120, Waukesha, WI, United States, 53186
Owner or operator
SHONEY SCIENTIFIC, INC. (2183650)
Roles
Repackager or relabeler
First device listed
October 25, 1996
Registered through
2026
Brand names listed
#1 Urinal, 1Scope-HD Blade (Disposable), AIROS 6P, AIROS 8P, BPS Ankle Fracture Implants, BPS Wrist Fracture Implants, Brecise, Cache Nipple Shields and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, NasopharyngealBTQ1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Bone Particle CollectorMXP1Repackager or relabeleraccessdata.fda.gov
Cannula, InjectionFGY1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)HHK2Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, General UseFZS1Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Repackager or relabeleraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeleraccessdata.fda.gov
Gown, ExaminationFME1Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Material, External Aesthetic Restoration, No AdhesiveNOK1Repackager or relabeleraccessdata.fda.gov
Material, External Aesthetic Restoration, Used With AdhesiveGBI1Repackager or relabeleraccessdata.fda.gov
Orthosis, Limb BraceIQI1Repackager or relabeleraccessdata.fda.gov
Paper, Obstetric PhLNW1Repackager or relabeleraccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Repackager or relabeleraccessdata.fda.gov
Plate, Fixation, BoneHRS2Repackager or relabeleraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-TypeHHF1Repackager or relabeleraccessdata.fda.gov
Scraper, TongueLCN1Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, BoneHWC2Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Repackager or relabeleraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Repackager or relabeleraccessdata.fda.gov
Sound, UterineHHM1Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Repackager or relabeleraccessdata.fda.gov
Stethoscope, ManualLDE1Repackager or relabeleraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Repackager or relabeleraccessdata.fda.gov
Tube, Smoke Removal, EndoscopicFCZ1Repackager or relabeleraccessdata.fda.gov
UrinalFNP1Repackager or relabeleraccessdata.fda.gov
Washer, Bolt NutHTN2Repackager or relabeleraccessdata.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
October 4, 2024K242343BPS Wrist Fracture SystemHRSSubstantially EquivalentOrthonovis, Inc.accessdata.fda.gov
December 9, 2022K223195AIROS 6P Sequential Compression DeviceJOWSubstantially EquivalentAiros Medical, Inc.accessdata.fda.gov
December 9, 2022K223193AIROS 8P Sequential Compression DeviceJOWSubstantially EquivalentAiros Medical, Inc.accessdata.fda.gov
January 17, 2014K130614BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERSHRSSubstantially EquivalentLaura Cattabrigaaccessdata.fda.gov
September 30, 2003K032161PHEM-ALERTLNWSubstantially EquivalentFemtek,Llc.accessdata.fda.gov
August 2, 2000K001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26HHKSubstantially EquivalentSims Portex , Ltd.accessdata.fda.gov
January 4, 2000K993463INTRAVASCULAR ADMINISTRATION SETFPASubstantially EquivalentCustom Assemblies, Inc.accessdata.fda.gov

Compare with other makers

Updated October 4, 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.