Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031962

FEI Number

3002445546

Entity Name

STALLION MEDICAL, INC.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

3085 Beyer Blvd Suite A-105, SAN DIEGO, CA 92154, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

STALLION MEDICAL, INC. (Owner Number: 9012225)

Owner / Operator Contact Address

3085 BEYER BLVD., SUITE A-105, --, SAN DIEGO, CA 92154, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121142

PMA Number

N/A

All Registered Proprietary Names

Orbital Implant Ophthamic Photocoagulator laser CORNEAL MARKER Measuring lens intrument Prescripcion Spectacle Lens Surgical Chisel CLAMP MUSCLE ophthalmic hook PUPILLOMETER MANUAL FORCEPS REFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER Face Mask KERATOMETER Respirator, surgical EYELID CLAMP Sunglasses Ophthalmic scissors CURETTE Analyzer Image Analyzer SPOON CANNULA OPHTHALMIC Non-surgical isolation gown Ophthalmic trial lens set Chart, Visual Acuity Ophthalmic microscope, non-electric FIXATION RING Thermometer, Clinical Mercury TREPHINE Magnifying Spectable ophthalmic conformer Otoscope Surgical Mallet Ophthalmic stand MASK, SCAVENGING Manual tonometer ophthalmic spatula Lachrymal Dilator Lachrimal Dilator IMPLANT, EYE SPHERE Trabeculotomy Probe OPHTHALMOSCOPE, BATTERY-POWERED Ophthalmic specula OPHTHALMOMETER OPHTHALMOMETER, OPHTHALMIC Ophthalmic Projector CALIPER Ophthalmic Electric instrument table Various types of Lens Loops Ophthalmic refractometer Punctum Plug STREAK AND SPOT RETINOSCOPE Lachrymal Probe RONGEUR NEEDLE HOLDERS Frame, spectacle Ophthalmic Retractor Tester, color vision SCLERAL DEPRESSOR THERMOMETER, CLINICAL COLOR CHANGE Intubation set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2016-11-21
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2008-01-08
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2007-07-11
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2007-07-16
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2020-05-05
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2013-03-22
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2018-01-24
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2014-10-30
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-23
HLQ	Keratoscope, Ac-Powered	Ophthalmic	Class 1	886.1350	2007-07-11
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-30
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2020-05-05
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-10-19
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-01-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-01-13
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-07-11
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-25
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2005-06-27
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2020-03-25
HRB	Microscope, Operating, Non-Electric, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2005-07-06
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2007-07-11
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2020-03-25
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2020-05-05
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2005-07-06
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2013-03-22
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-03-22
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2005-07-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-30
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2006-07-13
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-03-24
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2000-03-24
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2017-07-21
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2013-03-22
HLL	Monitor, Eye Movement	Ophthalmic	Class 2	886.1510	2014-10-30
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2014-10-30
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-07-11
HLF	Device, Measuring, Lens Radius, Ophthalmic	Ophthalmic	Class 1	886.1430	2018-01-24
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2005-06-27
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-07-11
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2005-07-06
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2013-03-22
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2005-07-06
LZU	Plug, Punctum	Unknown	Class U	N/A	2016-11-21
HKM	Retinoscope, Battery-Powered	Ophthalmic	Class 1	886.1780	2007-07-11
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2013-03-22
HNG	Rongeur, Lachrymal Sac	Ophthalmic	Class 1	886.4350	2007-07-11
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2000-03-24
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2017-07-21
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-22
HIT	Tester, Color Vision	Ophthalmic	Class 1	886.1170	2020-03-25
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2007-07-11
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2020-03-25
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2016-11-21

Official Correspondent

MARCELA GONZALEZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STALLION MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K834060	F. & F. Koenigkramer	RELIANCE OPHTHALMIC SLIT LAMP R-083	1984-02-04
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031962. Last updated year: 2026. Please use registration number 2031962 when referencing this establishment in official correspondence.