Data / Medical devices / Mexico / Stryker Tijuana Operations

Stryker Tijuana Operations: FDA-registered device maker in Tijuana Baja California, Mexico, 29 510(k) clearances

Name: Stryker Tijuana Operations FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Stryker Tijuana Operations is registered with the FDA (registration 3020163307) in Tijuana Baja California, Mexico. It lists 19 device types. The FDA files 29 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3020163307
Address: Ave. Todos los santos No. 10802 Col. Leandro Valle, Tijuana Baja California, Mexico, C.P. 22643
Owner or operator: STRYKER CORP. (1811755)
Roles: Contract manufacturer, Manufacturer, Reprocessor
First device listed: March 14, 1995
Registered through: 2027
Brand names listed: ACM, AEQUALIS PERFORM, AUTOPLEX, AutoPlex M4 Kit A: Cement Mixer with VertaPlex ® HV, AutoPlex M4 Kit B: Cement Mixer with VertaPlex ® HV Manifold compatible, Autoplex with Vertaplex HV, CABLE, ELECTRODE, Device, Transfer, Patient Manual, Reprocessed and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Reprocessor	accessdata.fda.gov
Bone Cement	LOD	2	Contract manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Reprocessor	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Contract manufacturer	accessdata.fda.gov
Device, Patient Transfer, Powered	FRZ	2	Reprocessor	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Reprocessor	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Reprocessor	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	NUJ	2	Reprocessor	accessdata.fda.gov
Gown, Surgical	FYA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hood, Surgical	FXY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery, Reprocessed	NLM	2	Reprocessor	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Contract manufacturer	accessdata.fda.gov
Monitor, Bed Patient	KMI	1	Reprocessor	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Reprocessor	accessdata.fda.gov
Oximeter, Reprocessed	NLF	2	Reprocessor	accessdata.fda.gov
Single-Use Reprocessed Ultrasonic Surgical Instruments	NLQ	U	Reprocessor	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Reprocessor	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Reprocessor	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 18, 2026	K260636	Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating	GEI	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
October 22, 2024	K241758	Reprocessed 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)	NLF	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
March 28, 2023	K230251	Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)	NUJ	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
December 4, 2022	K222019	Reprocessed 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)	NLF	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
May 25, 2022	K220481	Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)	GEI	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
March 8, 2022	K211140	Reprocessed 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 O2	DQA	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
March 8, 2022	K211138	Reprocessed 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)	NLF	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
March 21, 2020	K200493	Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover	FXY	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
April 23, 2018	K180499	Reprocessed LigaSure Maryland Jaw Sealer/Divider	NUJ	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
April 20, 2018	K180451	Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider	NUJ	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
November 16, 2017	K172856	Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider	GEI	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
April 5, 2017	K170456	Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology	NLQ	Substantially Equivalent	Stryker Sustainability Solutions	accessdata.fda.gov
August 26, 2014	K141095	STRYKER STERI-SHIELD FLYTE HYBRID TOGAS	FYA	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
June 26, 2014	K140588	FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS	FXY	Substantially Equivalent	Stryker Corporation	accessdata.fda.gov
July 23, 2010	K100909	REPROCESSED COMPRESSION SLEEVES	JOW	Substantially Equivalent	Ascent Healthcare Solutions	accessdata.fda.gov
July 29, 2008	K081238	REPROCESSED MASIMO PULSE OXIMETER SENSORS	NLF	Substantially Equivalent	Ascent Healthcare Solutions	accessdata.fda.gov
November 30, 2007	K073017	STRYKER STRI-SHIELD FLYTE TOGAS	FYA	Substantially Equivalent	Stryker Instruments, Instruments Div.	accessdata.fda.gov
March 23, 2007	K063005	STRYKER T6 HOODS AND TOGAS	FYA	Substantially Equivalent	Stryker Instruments	accessdata.fda.gov
October 11, 2006	K053585	VANGUARD REPROCESSED SUTURE PASSER	NLM	Substantially Equivalent	Ascent Healthcare Solutions	accessdata.fda.gov
February 24, 2006	K060049	REPROCESSED COMPRESSION SLEEVES	JOW	Substantially Equivalent	Alliance Medical Corp.	accessdata.fda.gov
February 17, 2006	K060091	ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES	JOW	Substantially Equivalent	Alliance Medical Corp.	accessdata.fda.gov
January 6, 2005	K042316	VANGUARD REPROCESSED PULSE OXIMETER SENSORS	NLF	Substantially Equivalent	Vanguard Medical Concepts, Inc.	accessdata.fda.gov
October 4, 2002	K012344	VANGUARD REPROCESSED PULSE OXIMETER SENSORS	NLF	Substantially Equivalent	Vanguard Medical Concepts, Inc.	accessdata.fda.gov
November 8, 2001	K012652	REPROCESSED DYONICS ARTHROSCOPIC BURS	HRX	Substantially Equivalent	Alliance Medical Corp.	accessdata.fda.gov
November 7, 2001	K012635	REPROCESSED STRYKER ARTHROSCOPIC SHAVERS	HRX	Substantially Equivalent	Alliance Medical Corp.	accessdata.fda.gov
November 7, 2001	K012613	REPROCSSED LINVATEC SHAVERS	HRX	Substantially Equivalent	Alliance Medical, Inc.	accessdata.fda.gov
November 7, 2001	K012605	REPROCESSED ATHROSCOPICS BURS	HRX	Substantially Equivalent	Alliance Medical Corp.	accessdata.fda.gov
October 16, 2001	K012346	VANGUARD REPROCESSED ARTHROSCOPIC BLADES	HRX	Substantially Equivalent	Vanguard Medical Concepts, Inc.	accessdata.fda.gov
February 19, 1991	K910512	ACCUFLATE	KCY	Substantially Equivalent	Instrumed, Inc.	accessdata.fda.gov

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Updated June 18, 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.