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Data / Medical devices / United States / FedEx Supply Chain, Inc.

FedEx Supply Chain, Inc.: FDA-registered device maker in Memphis, TN, United States, 31 510(k) clearances and 10 PMA approvals

FedEx Supply Chain, Inc. is registered with the FDA (registration 3013403214) in Memphis, TN, United States. It lists 50 device types. The FDA files 31 510(k) clearances and 10 PMA approvals under its listings, the newest dated October 26, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3013403214
Address
3955 E Holmes Rd, Memphis, TN, United States, 38118
Owner or operator
FedEx Supply Chain, Inc. (10053564)
Roles
Repackager or relabeler
First device listed
December 16, 2016
Registered through
2026
Brand names listed
Gore

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Absorbable Hemostatic, Non-Collagen BasedLMG3Repackager or relabeleraccessdata.fda.gov
Barrier, Absorbable, AdhesionMCN3Repackager or relabeleraccessdata.fda.gov
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Repackager or relabeleraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Repackager or relabeleraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Repackager or relabeleraccessdata.fda.gov
Cardiac Ablation Percutaneous CatheterLPB3Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Repackager or relabeleraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Repackager or relabeleraccessdata.fda.gov
Catheter, Intracardiac Mapping, High-Density ArrayMTD2Repackager or relabeleraccessdata.fda.gov
Catheter, IrrigationGBX1Repackager or relabeleraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Repackager or relabeleraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD3Repackager or relabeleraccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Repackager or relabeleraccessdata.fda.gov
Chair And Table, MedicalKMN1Repackager or relabeleraccessdata.fda.gov
Chart, Visual AcuityHOX1Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Repackager or relabeleraccessdata.fda.gov
Cutaneous Tissue Adhesive With MeshOMD2Repackager or relabeleraccessdata.fda.gov
Device, Communications, Images, OphthalmicNFG1Repackager or relabeleraccessdata.fda.gov
Device, Storage, Images, OphthalmicNFF1Repackager or relabeleraccessdata.fda.gov
Drape, Microscope, OphthalmicHMW2Repackager or relabeleraccessdata.fda.gov
Femtosecond Laser System For Refractive CorrectionOTL3Repackager or relabeleraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Repackager or relabeleraccessdata.fda.gov
Instrument, Quality-Assurance, RadiologicLHO1Repackager or relabeleraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Repackager or relabeleraccessdata.fda.gov
Light, Operating, DentalEAZ1Repackager or relabeleraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Repackager or relabeleraccessdata.fda.gov
Marker, OcularHMR1Repackager or relabeleraccessdata.fda.gov
Medical Device Data SystemOUG1Repackager or relabeleraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Repackager or relabeleraccessdata.fda.gov
Microscope, SurgicalEPT1Repackager or relabeleraccessdata.fda.gov
Microscope, Surgical, General & Plastic SurgeryFSO1Repackager or relabeleraccessdata.fda.gov
Ophthalmoscope, Ac-PoweredHLI2Repackager or relabeleraccessdata.fda.gov
Ophthalmoscope, Laser, ScanningMYC2Repackager or relabeleraccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Repackager or relabeleraccessdata.fda.gov
Perimeter, Ac-PoweredHOO1Repackager or relabeleraccessdata.fda.gov
Perimeter, Automatic, Ac-PoweredHPT1Repackager or relabeleraccessdata.fda.gov
PhotokeratoscopeHJA1Repackager or relabeleraccessdata.fda.gov
Refractometer, OphthalmicHKO1Repackager or relabeleraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, SyntheticGAN2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQ2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Repackager or relabeleraccessdata.fda.gov
Tomography, Optical CoherenceOBO2Repackager 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
October 26, 2016K161194PLEX Elite 9000 SS-OCTOBOSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
September 1, 2015K150977CIRRUS HD-OCTOBOSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
August 13, 2015K151200STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
July 2, 2015K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceNEWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
March 12, 2014K140318SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETEROBJSubstantially EquivalentBiosense Websteraccessdata.fda.gov
March 10, 2014K133864DERMABOND PRINEO SKIN CLOSURE SYSTEMOMDSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
February 28, 2014K132580COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
December 6, 2013K133356PROLENE POLYPROPYLENE NONABSORBABLE SUTUREGAWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
March 5, 2013K123837PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETERMTDSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
December 5, 2011K113213LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2DRFSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
November 18, 2011K112050SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETEROBJSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
May 2, 2011K101991WEBSTER DUO-DECAPOLAR CATHETERDRFSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
June 22, 2010K101345WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,DRFSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
November 25, 2009K093521GDXPROMYCSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
October 13, 2009K090017CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIESDQKSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
August 10, 2009K082016GDX VCC WITH ECC SOFTWAREMYCSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
April 23, 2008K080425CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02DRFSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
June 29, 2007K071234ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10FOBJSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 14, 2006K061463ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-SDRFSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
April 20, 2004K033123STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASEHLISubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
December 18, 2003K033746MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
July 22, 2003K031161VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETERDRFSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
September 13, 2002K022269COATED VICRYL* (POLYGLACTIN 910) SUTUREGAMSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
September 26, 2001K011877FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEMHKISubstantially EquivalentCarl Zeiss Jena GmbHaccessdata.fda.gov
August 31, 2000K002333BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220DRFSubstantially EquivalentBiosense Webster, Inc.accessdata.fda.gov
March 20, 2000K993357IOLMASTERHJOSubstantially EquivalentCarl Zeiss, Inc.accessdata.fda.gov
November 26, 1999K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRFSubstantially EquivalentCordis Webster, Inc.accessdata.fda.gov
October 4, 1999K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRFSubstantially EquivalentCordis Webster, Inc.accessdata.fda.gov
December 18, 1996K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGANSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
September 18, 1996K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRFSubstantially EquivalentCordis Webster, Inc.accessdata.fda.gov
January 9, 1995K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQSubstantially EquivalentETHICON, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
September 13, 2016P150040VISUMAX FEMTOSECOND LASEROTL23May 26, 2026accessdata.fda.gov
August 11, 2006P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB92September 15, 2026accessdata.fda.gov
November 5, 2004P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD135September 15, 2026accessdata.fda.gov
September 27, 2002P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD73February 26, 2025accessdata.fda.gov
June 15, 2000P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF72February 25, 2025accessdata.fda.gov
May 31, 2000P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB65December 23, 2025accessdata.fda.gov
September 30, 1997P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB86February 26, 2025accessdata.fda.gov
September 15, 1989P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIERMCN65June 25, 2026accessdata.fda.gov
January 28, 1982N18331PDS SUTURE (DYED)NEW27May 12, 1997accessdata.fda.gov
October 14, 1960N12159SURGICEL BRAND ABSORBABLE HEMOSTATLMG120July 28, 2026accessdata.fda.gov

Compare with other makers

Updated May 26, 2026. 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.