FDA.reportPublic FDA data

Stryker Tijuana Operations

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30201633073020163307Stryker Tijuana Operations1N2026-01-01Ave. Todos los santos No. 10802 Col. Leandro Valle Tijuana Baja California MX C.P. 22643

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2955691093391162K910512ACCUFLATEKCY1991-02-19
2955691037440798K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)NLF2024-10-22
2955691914854594K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ2023-03-28
2955691689282409K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)NLF2022-12-04
2955691072531902K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2DQA2022-03-08
2955691929428663K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)NLF2022-03-08
2955691151928210K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverFXY2020-03-21
2955691433760760K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ2018-04-23
2955691892650080K180451Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerNUJ2018-04-20
2955691788607175K172856Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/DividerGEI2017-11-16
2955691440294765K141095STRYKER STERI-SHIELD FLYTE HYBRID TOGASFYA2014-08-26
2955691076490000K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSFXY2014-06-26
2955691459009255K100909REPROCESSED COMPRESSION SLEEVESJOW2010-07-23
2955691626070173K081238REPROCESSED MASIMO PULSE OXIMETER SENSORSNLF2008-07-29
2955691522523303K073017STRYKER STRI-SHIELD FLYTE TOGASFYA2007-11-30
2955691875947578K063005STRYKER T6 HOODS AND TOGASFYA2007-03-23
2955691049785940K060091ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVESJOW2006-02-17
2955691041660009K060049REPROCESSED COMPRESSION SLEEVESJOW2006-02-24
2955691502305783K053585VANGUARD REPROCESSED SUTURE PASSERNLM2006-10-11
2955691906238750K042316VANGUARD REPROCESSED PULSE OXIMETER SENSORSNLF2005-01-06
2955691518610266K012344VANGUARD REPROCESSED PULSE OXIMETER SENSORSNLF2002-10-04
2955691185718428
2955691308396293
2955691397622904
2955691587469460
2955691715998030
2955691795816219
2955691903432166
2955691956560664

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NLF62024-10-22
NUJ32023-03-28
FYA32014-08-26
JOW32010-07-23
FXY22020-03-21
DQA12022-03-08
GEI12017-11-16
NLM12006-10-11
KCY11991-02-19