Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680271

FEI Number

3003259710

Entity Name

MEDSORB DOMINICANA, S.A.

City/State/Country

SAN PEDRO DE MACORIS, DO

Establishment Address

ZONA FRANCA INDUSTRIAL, SAN PEDRO DE MACORIS --, DO

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDSORB DOMINICANA, S.A. (Owner Number: 9007830)

Owner / Operator Contact Address

ZONA FRANCA INDUSTRIAL, --, SAN PEDRO DE MACORIS, DO-NOTA --, DO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VisiSorb BVI FABCO Omnia FABCO Flex-O-Blade Z-Medica FABCO NEUTEC FABCO IVALON Endostik FABCO FABCO FABCO FABCO FABCO CHAMPION FABCO IVALON Omnia FABCO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2019-12-09
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2013-02-12
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2000-09-07
EFN	Cotton, Roll	Dental	Class 1	872.6050	2023-09-01
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-28
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-11-01
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2018-12-05
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2011-05-27
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2011-05-27
POD	Temporary, Internal Use Hemostatic	General, Plastic Surgery	Class 2	878.4454	2019-12-09
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2009-12-30
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2010-03-25
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2010-03-25
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2019-12-09
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2019-12-09
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2020-06-10
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2025-12-15
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2011-05-27
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-03-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2011-05-27
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	1994-03-11
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-05-27
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2009-12-30
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-28
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2000-09-07
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-10-16
JES	Floss, Dental	Dental	Class 1	872.6390	2010-11-01
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-28
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2010-11-01
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2016-08-23
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	1994-03-11
PUK	Administration Set Securement Device	General Hospital	Class 1	880.5210	2021-03-19
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-28
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2013-02-12

Official Correspondent

No official correspondent registered.

US Agent Details

BETH CASLER Business: MEDSORB DOMINICANA, S.A. Email: beth@carwild.net Phone: (860) 4424914

Related Public Records

Same Entity

MEDSORB DOMINICANA, S.A.

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
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K823222	American Medical Optics	INTRAOCULAR LENS GUIDE	1982-12-28
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0835-2025	Alcon Research LLC	1	Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
Z-0006-2019	N/A	3	ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40, BA22-40/I13-40, BA22-110/I20-30, BA22-90/I20-30, BA22-70/I20-30, BA22-50/I20-30, BA22-110/I16-30, BA22-90/I16-30, BA22-70/I16-30, BA22-50/I16-30, BA22-100/I20-55, BA22-80/I20-55, BA22-100/I16-55, BA22-80/I16-55, BA25-120/I20-40, BA25-100/I20-40, BA25-80/I20-40, BA25-60/I20-40, BA25-40/I20-40, BA25-120/I16-40, BA25-100/I16-40, BA25-80/I16-40, BA25-60/I16-40, BA25-40/I16-40, BA25-120/I13-40, BA25-100/I13-40, BA25-80/I13-40, BA25-60/I13-40, BA25-40/I13-40, BA25-110/I20-30, BA25-90/I20-30, BA25-70/I20-30, BA25-50/I20-30, BA25-110/I16-30, BA25-90/I16-30, BA25-70/I16-30, BA25-50/I16-30, BA25-100/I20-55, BA25-80/I20-55, BA25-100/I16-55, BA25-80/I16-55, BA28-120/I20-40, BA28-100/I20-40, BA28-80/I20-40, BA28-60/I20-40, BA28-40/I20-40, BA28-120/I16-40, BA28-100/I16-40, BA28-80/I16-40, BA28-60/I16-40, BA28-40/I16-40, BA28-120/I13-40, BA28-100/I13-40, BA28-80/I13-40, BA28-60/I13-40, BA28-40/I13-40, BA28-110/I20-30, BA28-90/I20-30, BA28-70/I20-30, BA28-50/I20-30, BA28-110/I16-30, BA28-90/I16-30, BA28-70/I16-30, BA28-50/I16-30, BA28-100/I20-55, BA28-80/I20-55, BA28-100/I16-55, BA28-80/I16-55
Z-0007-2019	N/A	3	ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40, BEA22-60/I16-40, BEA22-40/I16-40, BEA22-120/I13-40, BEA22-100/I13-40, BEA22-80/I13-40, BEA22-60/I13-40, BEA22-40/I13-40, BEA22-110/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-40/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-40/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-40/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-40/I20-40, BEA28-120/I16-40, BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-40/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-40/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA28-90/I16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55
Z-0008-2019	N/A	3	ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100; Suprarenal Model #/REF: A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25/C75-O20, A25-25/C95-O20, A28-28/C55-O20, A28-28/C75-O20, A28-28/C95-O20, A31-31/C80-O20, A31-31/C100-O20, A34-34/C80-O20, A34-34/C100-O20; AFX Vela, Infrarenal Model #/REF: A22-22/C55V, A22-22/C75V, A22-22/C95V, A25-25/C55V, A25-25/C75V, A25-25/C95V, A28-28/C55V, A28-28/C75V, A28-28/C95V, A31-31/C80V, A31-31/C100V, A34-34/C80V, A34-34/C100V; Suprarenal Model #/REF: A22-22/C55-O20V, A22-22/C75-O20V, A22-22/C95-O20V, A25-25/C55-O20V, A25-25/C75-O20V, A25-25/C95-O20V, A28-28/C55-O20V, A28-28/C75-O20V, A28-28/C95-O20V, A31-31/C80-O20V, A31-31/C100-O20V, A34-34/C80-O20V, A34-34/C100-O20V
Z-0009-2019	N/A	3	ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX Stand Alone I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA, I20-13/C70F SA, I20-13/C88F SA, I20-20/C55 SA, I20-20/C55F SA, IS20-25/C55 SA, IF20-25/C65 SA, IS20-25/C65 SA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680271. Last updated year: 2026. Please use registration number 9680271 when referencing this establishment in official correspondence.