FDA Registration
Active
🇺🇸 United States
Welmed, Inc.
Reg #: 3005841027
·
FEI: 3005841027
·
Expires 2026
Products
33
Proprietary Names
40
Establishment Types
1
Classifications
33
Registration Details
- Registration Name
- Welmed, Inc.
- Registration Number
- 3005841027
- FEI Number
- 3005841027
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 401 N Michigan Ave Ste 1200
- City
- Chicago
- State
- IL
- ZIP
- 60611
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112057
Owner / Operator
- Firm Name
- Welmed, Inc.
- Operator Number
- 9089540
- Address
- 401 North Michigan Avenue, Suite 1200
- City
- Chicago
- State
- IL
- Postal Code
- 60611
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2007-03-15 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2008-01-03 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2010-12-27 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2007-03-15 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2018-07-31 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2013-06-27 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2013-06-27 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2011-04-17 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2019-05-08 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2021-05-27 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2007-03-15 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2007-03-15 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2019-05-29 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2007-03-15 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2007-03-15 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2019-04-10 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2007-03-15 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2010-07-13 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2007-03-15 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2009-11-18 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2008-04-28 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2019-03-18 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2016-07-11 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2007-03-15 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2007-03-15 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2010-03-26 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-02-13 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2010-02-25 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2023-12-05 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2022-11-02 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2023-12-05 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-11-09 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2008-01-03 |
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
Suture Bag
Clamp
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
Evacuator, Oral Cavity
INSTRUMENT, SURGICAL, DISPOSABLE
Surgical Drapes, Thermal/Warming
Slush/Warming Drapes
Band Bags, Dome Bags and Set Up Covers
Tape and Bandage, Adhesive
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility