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Data / Medical devices / United States / Mazza Healthcare LLC

Mazza Healthcare LLC: FDA-registered device maker in Lincolnshire, IL, United States, 10 510(k) clearances

Mazza Healthcare LLC is registered with the FDA (registration 3007407626) in Lincolnshire, IL, United States. It lists 38 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 15, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Mazza Healthcare LLC
FDA registration number
3007407626
Address
100 Tri State Intl Ste 125, Lincolnshire, IL, United States, 60069
Owner or operator
Mazza Healthcare, LLC (10028309)
Roles
Complaint file establishment
First device listed
May 29, 2019
Registered through
2026
Brand names listed
Aesculap, HCS, MH, Mazza, Mazza Healthcare

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Complaint file establishmentaccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Complaint file establishmentaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Complaint file establishmentaccessdata.fda.gov
Basin, EmesisFNY1Complaint file establishmentaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Complaint file establishmentaccessdata.fda.gov
Blood Pressure CuffDXQ2Complaint file establishmentaccessdata.fda.gov
Cap, SurgicalFYF1Complaint file establishmentaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishmentaccessdata.fda.gov
Counter, Sponge, SurgicalLWH1Complaint file establishmentaccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Complaint file establishmentaccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Complaint file establishmentaccessdata.fda.gov
Drape, Surgical, ExemptPUI2Complaint file establishmentaccessdata.fda.gov
Fentanyl And Other Opioid Protection GloveQDO1Complaint file establishmentaccessdata.fda.gov
ForcepsHTD1Complaint file establishmentaccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Complaint file establishmentaccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Complaint file establishmentaccessdata.fda.gov
Gown, ExaminationFME1Complaint file establishmentaccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Complaint file establishmentaccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Complaint file establishmentaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Complaint file establishmentaccessdata.fda.gov
Mask, SurgicalFXX2Complaint file establishmentaccessdata.fda.gov
Medical Glove, SpecialtyLZC1Complaint file establishmentaccessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsOPJ1Complaint file establishmentaccessdata.fda.gov
Non-Surgical GownOEA1Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Complaint file establishmentaccessdata.fda.gov
Pad, Heating, PoweredIRT2Complaint file establishmentaccessdata.fda.gov
Pill Crusher/CutterOHY1Complaint file establishmentaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Complaint file establishmentaccessdata.fda.gov
RetractorGAD1Complaint file establishmentaccessdata.fda.gov
Scale, PatientFRW1Complaint file establishmentaccessdata.fda.gov
Scale, Stand-On, PatientFRI1Complaint file establishmentaccessdata.fda.gov
Scissors, General, SurgicalLRW1Complaint file establishmentaccessdata.fda.gov
Stethoscope, ManualLDE1Complaint file establishmentaccessdata.fda.gov
Syringe, PistonFMF2Complaint file establishmentaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishmentaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishmentaccessdata.fda.gov
Vinyl Patient Examination GloveLYZ1Complaint file establishmentaccessdata.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
March 15, 2023K223375Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.LZASubstantially EquivalentKossan International Sdn Bhd3accessdata.fda.gov
January 5, 2022K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXNSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
July 7, 2021K210524Surgical MaskFXXSubstantially EquivalentChangzhou Holymed Products Co., Ltd.accessdata.fda.gov
June 18, 2019K191209Aneroid Type Blood Pressure KitDXQSubstantially EquivalentDongguan Mars Medical Products Co., Ltd.accessdata.fda.gov
November 20, 2018K181857Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZASubstantially EquivalentKossan International Sdn Bhdaccessdata.fda.gov
November 8, 2017K171131MHC Standard and NRFit Tip SyringesFMFSubstantially EquivalentMazza Healthcare, LLCaccessdata.fda.gov
September 19, 2017K163518Digital ThermometerFLLSubstantially EquivalentJoytech Healthcare Co. , Ltd.accessdata.fda.gov
August 3, 2016K151750Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-SterileLZASubstantially EquivalentKossan International Sdn Bhdaccessdata.fda.gov
December 30, 2002K022091BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVESLYZSubstantially EquivalentTangshan Zhonghong Pulin Group Co., Ltd.accessdata.fda.gov
August 16, 2001K012444ABN ANEROID SPHYGMOMANOMETERDXQSubstantially EquivalentPt. Sugih Instrumendo Abadiaccessdata.fda.gov

Compare with other makers

Updated March 15, 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.