Establishment Registration & Device Listing

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Establishment
Name

Registration Number

Current
Registration Yr

2H MANUFACTURING & DISTRIBUTING CORP.

NV/USA

3005353770

2026

2nd Sight Medical Co., Ltd.

CHINA

3023017972

2026

knife, ophthalmic - Disposable Sterile Ophthalmic Surgical Knives

Manufacturer

2SAN LLC

NY/USA

3025041446

2026

diazo (colorimetric), nitrite (urinary, non-quant) - 2San Urinary Tract Infection Test

Complaint File Establishment

test, urine leukocyte - 2San Urinary Tract Infection Test

Complaint File Establishment

enzyme immunoassay, phencyclidine - 2San Home Drug Test - 1 Panel (COC); 2San Home Drug Test - 1 Panel (THC); 2San Home Drug Test - 14 Panel; 2San Home Drug Test - 4 Panel; 2San Home Drug Test - 7 Panel

Complaint File Establishment

test, amphetamine, over the counter - 2San Home Drug Test - 1 Panel (COC); 2San Home Drug Test - 1 Panel (THC); 2San Home Drug Test - 14 Panel; 2San Home Drug Test - 4 Panel; 2San Home Drug Test - 7 Panel

Complaint File Establishment

test, benzodiazepine, over the counter - 2San Home Drug Test - 1 Panel (COC); 2San Home Drug Test - 1 Panel (THC); 2San Home Drug Test - 14 Panel; 2San Home Drug Test - 4 Panel; 2San Home Drug Test - 7 Panel

Complaint File Establishment

Show all 20 Listings for 2SAN LLC NY/USA

2VIEW, LLC

VA/USA

3006115103

2026

container, specimen, non-sterile - 2VIEW SPECIMEN CONTAINER

Specification Developer

3-D MATRIX EUROPE SAS

FRANCE

3012263097

2026

polymer, ear, nose and throat, synthetic, absorbable

Specification Developer

hemostatic device for endoscopic gastrointestinal use

Specification Developer

protective coating, mucoadhesive application, for the rectal mucosa

Specification Developer

hemostatic device for endoscopic gastrointestinal use

Manufacturer; Complaint File Establishment

protective coating, mucoadhesive application, for the rectal mucosa

Manufacturer; Complaint File Establishment

Show all 9 Listings for 3-D MATRIX EUROPE SAS FRANCE

3-D MATRIX, INC.

MA/USA

3015528146

2026

polymer, ear, nose and throat, synthetic, absorbable - PuraGel; PuraSinus

Manufacturer; Complaint File Establishment

hemostatic device for endoscopic gastrointestinal use - PuraStat

Manufacturer; Complaint File Establishment

connector, catheter - Syringe Adapter

Specification Developer; Complaint File Establishment

dressing, wound and burn, hydrogel w/drug and/or biologic - PuraGel; PuraSinus - Oral Mucosa

Manufacturer; Complaint File Establishment

oral wound dressing - PuraGel; PuraSinus - Oral Mucosa

Manufacturer; Complaint File Establishment

3-D MATRIX, LTD.

JAPAN

3007162658

2026

polymer, ear, nose and throat, synthetic, absorbable - PuraGel

Foreign Exporter

hemostatic device for endoscopic gastrointestinal use - PuraStat

Foreign Exporter

connector, catheter - Syringe Adapter

Foreign Exporter; Manufacturer

3-POINT PRODUCTS, INC.

MD/USA

3007257878

2026

massager, therapeutic, manual - SkinSational

Repackager/Relabeler; Specification Developer

splint, hand, and components - 2-Strap Wrist & Tumb Splint; 3pp Arch Lift; 3pp Buddy Loops; 3pp Bunion-Aider; 3pp Carpal Lift; 3pp Carpal Lift NP; 3pp Design Line Thumb Splint; 3pp Elbow P.O.P.; 3pp Elbow Wrap; 3pp Final Flexion Wrap; 3pp Finger Sling; 3pp Finger Trapper; 3pp Gel Tubes; 3pp PF Lift; 3pp Removable Stays; 3pp Side Step Splint; 3pp Step Down Splint; 3pp Step Up Splint; 3pp ThumDuction Strap; 3pp ThumSling; 3pp ThumSling Long; 3pp ThumSling Long NP; 3pp ThumSling NP; 3pp ThumSock; 3pp ThumSpica; 3pp THumSpica Plus; 3pp Toe Loops; 3pp U Wrap; 3pp Ultra MP; 3pp Ultra Spica; 3pp Wrist P.O.P.; 3pp Wrist Wrap; 3pp Wrist Wrap NP; Cindy Splint; CMCcare Thumb Brace; Comforter Splint; D.I.T.H.; Easy-Lace Protective Wrist & Thumb Splint; Easy-Lace Protective Wrist Splint; Manutec Short-Semi Rigid Wrist Support with Thumb Splint; Manutec-Fix Thumb Splint; Manutec-Fix Wrist Splint; Oval-8 Finger Splint; Polycentric Hinged Ulnar Deviation Splint; R.O.M.E.O.; Radial Hinged Ulnar Deviation Splint; ThumSaver CMC Long; ThumSaver CMC Short; ThumSaver MP; Wrist Control

Repackager/Relabeler; Specification Developer

elastomer, silicone, for scar management - Gel Mate Silicone Gel Sheet; Scar Rx

Repackager/Relabeler; Specification Developer

316 CONTRACT MANUFACTURING LLC

IN/USA

3038772438

2026

ventilator, emergency, manual (resuscitator) - butterflyBVM

Contract Manufacturer

35NEWTONS, LLC

WA/USA

3012930250

2026

accessories, implant, dental, endosseous

Specification Developer

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Establishment Registration & Device Listing

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