Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219313

FEI Number

1219313

Entity Name

CARWILD CORP.

City/State/Country

NEW LONDON, CT, US

Establishment Address

3 State Pier Rd, NEW LONDON, CT 06320, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CARWILD CORPORATION (Owner Number: 1219313)

Owner / Operator Contact Address

3 STATE PIER ROAD, --, New London, CT 06320, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FABCO IVALON GENESIS FABCO ENDOSTIK HYDRASORB FABCO IVALON FABCO FABCO IVALON FABCO FABCO Omnia HYDRASORB DALE MEDICAL PRODUCTS FABCO FABCO IVALON FABCO Flex-O-Blade FABCO CHAMPION DALE MEDICAL PRODUCTS

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
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2010-03-25
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2011-05-27
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2010-03-18
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-08-17
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-12-30
POD	Temporary, Internal Use Hemostatic	General, Plastic Surgery	Class 2	878.4454	2019-12-09
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2023-12-13
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-10-16
KCN	Ear Wick	Ear, Nose, Throat	Class 1	874.5220	2011-05-27
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2010-03-25
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2013-02-12
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2016-08-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-05-27
PUK	Administration Set Securement Device	General Hospital	Class 1	880.5210	2023-12-13
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2016-07-08
EFN	Cotton, Roll	Dental	Class 1	872.6050	2023-09-01
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-12-30
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-29
MGP	Dressing, Wound And Burn, Occlusive	Unknown	Class U	N/A	2008-12-30
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2019-12-09
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2010-03-18
HBA	Neurosurgical Paddie	Neurology	Class 2	882.4700	2018-12-05
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	1979-08-17
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-10-16
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-29
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-29
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-29
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2011-05-27
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2013-02-12
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2025-12-15
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2016-07-08
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2014-05-29
JES	Floss, Dental	Dental	Class 1	872.6390	2010-12-30
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2019-12-09
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2010-03-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CARWILD CORPORATION

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
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
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219313. Last updated year: 2026. Please use registration number 1219313 when referencing this establishment in official correspondence.