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Data / Medical devices / United States / Ranfac Corp.

Ranfac Corp.: FDA-registered device maker in Avon, MA, United States, 15 510(k) clearances

Ranfac Corp. is registered with the FDA (registration 1211566) in Avon, MA, United States. It lists 28 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 18, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
1211566
Address
30 Doherty Ave, Avon, MA, United States, 02322
Owner or operator
Ranfac Corp. (1211566)
Roles
Contract manufacturer, Manufacturer
First device listed
December 20, 1977
Registered through
2027
Brand names listed
30G-END, 31G-END, ASK-1 - Aspiration Starter Kit, Access Needle, Accuport, BMAT, BMET, BMT and more

Devices it lists

DeviceProduct codeClassRoleSource
Biopsy NeedleFCG2Contract manufacturer, Manufactureraccessdata.fda.gov
Biopsy Needle KitPOZ2Manufactureraccessdata.fda.gov
Cannula, InjectionFGY1Manufactureraccessdata.fda.gov
Catheter, CholangiographyGBZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Contract manufacturer, Manufactureraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufactureraccessdata.fda.gov
Filters, Cell Collection, Tissue ProcessingKET1Manufactureraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Contract manufacturer, Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, BiopsyKNW2Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Contract manufacturer, Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufacturer, Manufactureraccessdata.fda.gov
Marker, Radiographic, ImplantableNEU2Contract manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, CatheterGCB1Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Contract manufactureraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Contract manufactureraccessdata.fda.gov
Platelet And Plasma Separator For Bone Graft HandlingORG2Manufactureraccessdata.fda.gov
Pneumoperitoneum NeedleFHO2Contract manufacturer, Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, NerveETN2Contract manufactureraccessdata.fda.gov
System, Suction, LipoplastyMUU2Contract manufacturer, Manufactureraccessdata.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
September 18, 2020K202287Ran-Flex-B Bone Marrow Aspiration NeedleKNWSubstantially EquivalentRanfac Corporationaccessdata.fda.gov
June 12, 2019K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,KNWSubstantially EquivalentRanfac Corporationaccessdata.fda.gov
April 25, 2019K183146Ranfac Cartilage Biopsy NeedleKNWSubstantially EquivalentRanfac Corporationaccessdata.fda.gov
January 19, 2017K162932Ranfac Fat Aspiration CannulaMUUSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
October 19, 2015K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment VesselMUUSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
May 22, 2015K150563Marrow Cellution Bone Marrow Aspiration NeedleKNWSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
September 11, 2014K140991RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDEKNWSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
October 22, 2013K131157RANFAC BONE MARROW ASPIRATION NEEDLEKNWSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
August 22, 2001K012224SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROWKNWSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
December 10, 1998K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLEKNWSubstantially EquivalentMedsol Corp.accessdata.fda.gov
August 9, 1996K961922RDP-2HETSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
July 11, 1995K951090INTRODUCERGCJSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
July 23, 1993K930474NEEDLE, PNEUMOPERITONEUM, SPRING LOADEDFHOSubstantially EquivalentRanfac, Corp.accessdata.fda.gov
November 5, 1986K864139RANFAC CUT BIOPSY NEEDLEGAASubstantially EquivalentRanfac, Corp.accessdata.fda.gov
March 11, 1985K845038BREAST & FOREIGN BODY LOCALIZATION INSTRUMENTGDFSubstantially EquivalentRanfac, Corp.accessdata.fda.gov

Compare with other makers

Updated September 18, 2020. 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.