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
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2016 | K161194 | PLEX Elite 9000 SS-OCT | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| September 1, 2015 | K150977 | CIRRUS HD-OCT | OBO | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| August 13, 2015 | K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 2, 2015 | K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 12, 2014 | K140318 | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Biosense Webster | accessdata.fda.gov |
| March 10, 2014 | K133864 | DERMABOND PRINEO SKIN CLOSURE SYSTEM | OMD | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| February 28, 2014 | K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 5, 2013 | K123837 | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER | MTD | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| December 5, 2011 | K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 18, 2011 | K112050 | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER | OBJ | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| May 2, 2011 | K101991 | WEBSTER DUO-DECAPOLAR CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 22, 2010 | K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| November 25, 2009 | K093521 | GDXPRO | MYC | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| October 13, 2009 | K090017 | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES | DQK | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| August 10, 2009 | K082016 | GDX VCC WITH ECC SOFTWARE | MYC | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| April 23, 2008 | K080425 | CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| June 29, 2007 | K071234 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F | OBJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 14, 2006 | K061463 | ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| April 20, 2004 | K033123 | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE | HLI | Substantially Equivalent | Carl Zeiss Meditec, Inc. | accessdata.fda.gov |
| December 18, 2003 | K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 22, 2003 | K031161 | VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| September 13, 2002 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 26, 2001 | K011877 | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM | HKI | Substantially Equivalent | Carl Zeiss Jena GmbH | accessdata.fda.gov |
| August 31, 2000 | K002333 | BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 | DRF | Substantially Equivalent | Biosense Webster, Inc. | accessdata.fda.gov |
| March 20, 2000 | K993357 | IOLMASTER | HJO | Substantially Equivalent | Carl Zeiss, Inc. | accessdata.fda.gov |
| November 26, 1999 | K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| October 4, 1999 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| December 18, 1996 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 18, 1996 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | DRF | Substantially Equivalent | Cordis Webster, Inc. | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 13, 2016 | P150040 | VISUMAX FEMTOSECOND LASER | OTL | 23 | May 26, 2026 | accessdata.fda.gov |
| August 11, 2006 | P040036 | NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER | LPB | 92 | September 15, 2026 | accessdata.fda.gov |
| November 5, 2004 | P030031 | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | OAD | 135 | September 15, 2026 | accessdata.fda.gov |
| September 27, 2002 | P010068 | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | OAD | 73 | February 26, 2025 | accessdata.fda.gov |
| June 15, 2000 | P990025 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | DRF | 72 | February 25, 2025 | accessdata.fda.gov |
| May 31, 2000 | P990071 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | LPB | 65 | December 23, 2025 | accessdata.fda.gov |
| September 30, 1997 | P950005 | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER | LPB | 86 | February 26, 2025 | accessdata.fda.gov |
| September 15, 1989 | P880047 | INTERCEED TC7 ABSORBABLE ADHESION BARRIER | MCN | 65 | June 25, 2026 | accessdata.fda.gov |
| January 28, 1982 | N18331 | PDS SUTURE (DYED) | NEW | 27 | May 12, 1997 | accessdata.fda.gov |
| October 14, 1960 | N12159 | SURGICEL BRAND ABSORBABLE HEMOSTAT | LMG | 120 | July 28, 2026 | accessdata.fda.gov |
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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.