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Ranfac, Corp.

FDA Regulatory Profile

Ranfac, Corp. has 0 FDA recalls, 2 inspections, 16 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 6, 2014 · VAI
Latest 510(k)
Feb 21, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances16Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 6, 2014Avon, MADevicesVoluntary Action Indicated (VAI)1211566
Jul 13, 2011Avon, MADevicesVoluntary Action Indicated (VAI)1211566

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Feb 21, 2023
K202287Ran-Flex-B Bone Marrow Aspiration NeedleSep 18, 2020
K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Jun 12, 2019
K183146Ranfac Cartilage Biopsy NeedleApr 25, 2019
K162932Ranfac Fat Aspiration CannulaJan 19, 2017
K150156Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe…Oct 19, 2015
K150563Marrow Cellution Bone Marrow Aspiration NeedleMay 22, 2015
K140991RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDESep 11, 2014
K131157RANFAC BONE MARROW ASPIRATION NEEDLEOct 22, 2013
K031344RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLEMay 23, 2003
K012224SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROWAug 22, 2001
K961922RDP-2Aug 9, 1996
K951090INTRODUCERJul 11, 1995
K930474NEEDLE, PNEUMOPERITONEUM, SPRING LOADEDJul 23, 1993
K864139RANFAC CUT BIOPSY NEEDLENov 5, 1986
K845038BREAST & FOREIGN BODY LOCALIZATION INSTRUMENTMar 11, 1985

FDA data resources