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Data / Medical devices / United States / Busse Hospital Disposables

Busse Hospital Disposables: FDA-registered device maker in Hauppauge, NY, United States, 22 510(k) clearances

Busse Hospital Disposables is registered with the FDA (registration 2433012) in Hauppauge, NY, United States. It lists 78 device types. The FDA files 22 510(k) clearances under its listings, the newest dated January 5, 2018. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Busse Hospital Disposables
FDA registration number
2433012
Address
75 Arkay DR., Hauppauge, NY, United States, 11788
Owner or operator
ROBERT BUSSE & CO., INC. (2417536)
Roles
Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
December 20, 1977
Registered through
2026
Brand names listed
"T" Connector, 1 oz Bulb Syringe, 10' x 1/4" ID Suction Tubing, 10ml LOR Luer Lock Syringe - 5950, 10ml LOR Luer Slip Syringe - 5960, 10mm Curved Curette, 10mm Straight Connector, 10mm Straight Curette and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Manufacturer, Repackager or relabeleraccessdata.fda.gov
AmniotomeHGE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Anesthesia Conduction KitCAZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Apron, ProtectiveIWO1Repackager or relabeleraccessdata.fda.gov
Arthrogram TrayOII2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Repackager or relabeleraccessdata.fda.gov
Bag, IceKYR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cap, SurgicalFYF1Repackager or relabeleraccessdata.fda.gov
Catheter, PeritonealGBW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cesarean Section TrayOHM2Contract manufactureraccessdata.fda.gov
Circumcision TrayOHG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Clamp, UmbilicalHFW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Colonic Irrigation SystemKPL2Contract manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Curette, UterineHCY1Manufacturer, Specification developeraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufactureraccessdata.fda.gov
Epidural Anesthesia KitOGE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Eye TrayOJK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gastro-Urology Biopsy KitPRV2Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Gown, Isolation, SurgicalFYC2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hysteroscope AccessoriesNWW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
I.V. Start KitLRS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, BiopsyKNW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Clip Forming/CuttingHBS1Repackager or relabeleraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Manufactureraccessdata.fda.gov
Intravenous Extension Tubing SetOJA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufacturer for exportaccessdata.fda.gov
Label Or Tag, SterileLYV1Manufactureraccessdata.fda.gov
Laparoscopy KitFDE2Manufactureraccessdata.fda.gov
Lumbar Puncture Tray (Adult & Pediatric)PWY2Manufacturer, Manufacturer for export, Repackager or relabeleraccessdata.fda.gov
Manometer, Spinal-FluidFMJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mri Disposable KitOIM2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, CatheterGCB1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Nerve Block TrayOGJ2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Neurological TrayOJG1Contract manufactureraccessdata.fda.gov
Obstetrical KitOKV2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pad, Menstrual, UnscentedHHD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pelvic Exam KitMLT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Peripheral Catheter Insertion KitOWL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plastic Surgery And Accessories KitFTN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Contract manufactureraccessdata.fda.gov
Qualitative Chemical Reactions, Urinary Calculi (Stone)JNQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sampler, Amniotic Fluid (Amniocentesis Tray)HIO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Suture Removal KitMCZ1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Tracheotomy Care KitNXA2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, Biopsy, Without Biopsy InstrumentsFCH1Manufacturer, Manufacturer for export, Repackager or relabeleraccessdata.fda.gov
Tray, Start/Stop (Including Contents), DialysisFKG1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
TrocarDRC2Contract manufacturer, Manufactureraccessdata.fda.gov
Trocar, Gastro-UrologyFBQ2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tubing, Fluid DeliveryFPK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Manufactureraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Manufactureraccessdata.fda.gov
Wound Dressing KitMCY2Manufacturer, Manufacturer for export, Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Manufacturer, Repackager 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
January 5, 2018K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesBSPSubstantially EquivalentZhejiang Kindly Medical Devices Co., Ltd.accessdata.fda.gov
December 22, 2015K142125New Medax Biopsy SystemsKNWSubstantially EquivalentMedax Srl Unipersonaleaccessdata.fda.gov
February 19, 2015K141285BUSSE EXTENSION SETFPASubstantially EquivalentBusse Hospital Disposablesaccessdata.fda.gov
December 6, 2013K131006ANESTHESIA CONDUCTION NEEDLESBSPSubstantially EquivalentLccs Products Limitedaccessdata.fda.gov
June 26, 2012K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLEKNWSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
June 8, 2011K110883J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULAKNWSubstantially EquivalentBusse Hospital Disposablesaccessdata.fda.gov
May 27, 2011K092338MEDAX UNIPERSONALE SRLKNWSubstantially EquivalentMedax Unipersonale Srlaccessdata.fda.gov
July 9, 2008K080804BUSSE PLASTIC LOR SYRINGECAZSubstantially EquivalentBusse Hosipital Disposablesaccessdata.fda.gov
May 24, 2007K070801IMM HYPODERMIC NEEDLE SETFPASubstantially EquivalentInnovative Medical Manufacturing Co.accessdata.fda.gov
January 22, 2007K063018GLASS LOSS OF RESISTANCE SYRINGECAZSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
December 18, 2006K061737LOSS OF RESISTANCE SYRINGECAZSubstantially EquivalentRobert Busse & Co., Inc.accessdata.fda.gov
September 6, 2006K061394SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)BSPSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
July 3, 2006K061570I-STYLE BONE MARROW ASPIRATION NEEDLEKNWSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
April 17, 2006K052843BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBEFMISubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
August 28, 2003K032432BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETERFMJSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
April 30, 2001K010835POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385HFWSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
June 11, 1998K980987BECTON DICKINSON SYRINGEFMFSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
July 14, 1995K952334DRESSING CHANGE TRAYMCYSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
May 10, 1995K941845BUSE STAFF PROTECTION GOWNS AND KITSFYCSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
November 2, 1994K940720BUSSE ISOLATION AND PROCEDURAL MASKSFXXSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov
December 16, 1993K931202STERILIZATION WRAP-STERISHEETFRGSubstantially EquivalentArjo Wiggins Medical, Inc.accessdata.fda.gov
October 22, 1986K863712I.V. START KIT, STERILE, DISPOSABLESLRSSubstantially EquivalentBusse Hospital Disposables, Inc.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
November 30, 202393546Class IOngoingCatalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREEFirm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the accessdata.fda.gov
October 21, 202291079Class IIOngoingBusse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusableaccessdata.fda.gov
February 22, 202290072Class IITerminatedI.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug productsaccessdata.fda.gov
June 27, 201778950Class IITerminatedSafety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedureBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.accessdata.fda.gov
November 15, 201675746Class IITerminatedCARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.accessdata.fda.gov
April 13, 200428815Not yet classifiedTerminatedSuction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made iFirm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.accessdata.fda.gov

Compare with other makers

Updated January 3, 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.