Norfolk Medical Products, Inc.

FDA Regulatory Profile

Norfolk Medical Products, Inc. has 0 FDA recalls, 5 inspections, 20 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 18, 2024 · NAI
Latest 510(k)
Aug 20, 2020

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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) clearances20Oct 4, 2026Not statedCurrent
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 18, 2024Skokie, ILDevicesNo Action Indicated (NAI)1450392
Jul 26, 2022Skokie, ILDevicesNo Action Indicated (NAI)1450392
Nov 2, 2018Skokie, ILDevicesVoluntary Action Indicated (VAI)1450392
Feb 11, 2015Skokie, ILDevicesNo Action Indicated (NAI)1450392
Feb 4, 2010Skokie, ILDevicesNo Action Indicated (NAI)1450392

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
K192291TidalPort-AP Implantable Apheresis Vascular Access PortAug 20, 2020
K112713NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTSOct 27, 2011
K102385NORFOLK MEDICAL NORPORT FAMILY OF PORTSJan 14, 2011
K942784NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTEDMay 2, 1995
K896544MD2 PERSONAL INFUSION SYSTEMMay 2, 1990
K872838NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)Aug 25, 1987
K871209NORFOLK MEDICAL NORPORTJun 24, 1987
K871192SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOTJun 10, 1987
K870187NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOTMay 7, 1987
K870519SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOTApr 15, 1987
K870188NORFOLK MEDICAL BUTTERFLY INFUSION SETFeb 10, 1987
K863723NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOTOct 29, 1986
K863721NORFOLK MEDICAL POSI-GRIP 'HUBER POINT' NEEDLEOct 14, 1986
K854593NORFOLK MEDICAL PERITONEAL-ACCESS PORTFeb 4, 1986
K841679VASCULAR-ACCESS-PORT WITHDRAWL-BLOODJun 28, 1984
K841149VASCULAR-ACCESS PORT - ENLARGEMENTApr 24, 1984
K840788VASCULAR ACCESS PORT CHANGES IN MATERApr 24, 1984
K841150VASCULAR-ACCESS PORT CHANGE CATHETERApr 24, 1984
K823845PORT-LOCKMar 1, 1983
K830000VASCULAR-ACCESS-PORTMar 1, 1983