Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005841027

FEI Number

3005841027

Entity Name

Welmed, Inc.

City/State/Country

Chicago, IL, US

Establishment Address

401 N Michigan Ave Ste 1200, Chicago, IL 60611, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Welmed, Inc. (Owner Number: 9089540)

Owner / Operator Contact Address

401 North Michigan Avenue, Suite 1200, Chicago, IL 60611, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130212

PMA Number

N/A

All Registered Proprietary Names

Catheter, Continuous Irrigation Tubing, Noninvasive FORCEPS Restraint, protective Gown, Examination Dressing, Wound, Occlusive Counter, sponge, surgical Cover, Shoe, Operating-Room Clamp, Surgical, Gerneral and Plastic Surgery Syringe, piston Endoscopic Bite Block Hypodermic Syringes SURGICAL TOWEL Face Shield PATIENT DRAPES Slides, Microscope BANDAGE ELASTIC ULTRA-WEAVE PREM-WEAVE EAR SYRINGE IRRIGATION BULB CONTAINER, SPECIMEN, NON-STERILE Lift, patient, non-ac-powered Camera, Surgical and Accessories COTTON STOCKINETTE CAST PADDING Surgical Cap Syringe, Piston

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2007-03-15
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2008-01-03
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2010-12-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-03-15
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2018-07-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-06-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-06-27
FME	Gown, Examination	General Hospital	Class 1	880.6265	2011-04-17
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-05-08
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2021-05-27
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2007-03-15
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-03-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-05-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-05-28
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2019-05-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-04-19
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2007-03-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2007-03-15
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2019-04-10
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2007-03-15
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-07-13
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2007-03-15
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2009-11-18
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-04-28
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2019-03-18
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2016-07-11
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2007-03-15
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2007-03-15
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-03-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-05-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Welmed, 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
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005841027. Last updated year: 2026. Please use registration number 3005841027 when referencing this establishment in official correspondence.