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Sign in to claim this brandDale Medical Products, Inc.
United States·US-MF-000019061
Last updated September 17, 2026
About
Customer Survey We value your feedback and it helps us to continue to make Dale Always Better. Perspectives in Nursing Since 2001 Dale has been the proud
From the manufacturer's own website. Source
What Dale Medical Products, Inc. makes
The company manufactures reusable and single-use medical accessories for patient care, including endotracheal tube holders, tracheostomy tube neck holders, and reusable armboards. It also produces sterile enteral feeding kits for adults and children, noninvasive nasogastric tube holders, urinary catheter holders, and non-adhesive retention bandages. Electrode/transducer straps and adhesive bases for securing medical devices are part of its portfolio, alongside specialized connectors like the ENFit ACE for enteral feeding systems.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with listings in the EU’s eudamed database, the FDA’s 510(k) premarket notification program, and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 40, Kenwood Circle, Franklin, United States
- Website
- www.dalemed.com
- linkedin.com/company/dalemedical
- facebook.com/DaleMedicalProducts
- [email protected]
- Phone
- 1.508.695.9316
- PRRC Contact
- Raymond Gruneberg
- EUDAMED SRN
- US-MF-000019061
- FDA FEI Number
- 1214422
- DUNS Number
- —
Catalogue (119)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dale Post-Surgical Bra, XXX-Large | 706 | EUDAMEDFDA UDI | Class I | Active |
| Dale Abdominal Binder | 525 | EUDAMEDFDA UDI | Class I | Active |
| Dale Bendable Armboard | 653 | EUDAMEDFDA UDI | Class I | Active |
| Hold-n-Place Adhesive Patch | 150 | EUDAMEDFDA UDI | Class I | Active |
| Dale NasoGastric Tube Holder | 160 | EUDAMEDFDA UDI | Class I | Active |
| Dale Bendable Armboard | 651 | EUDAMEDFDA UDI | Class I | Active |
| Dale IV Line Manager | 630 | EUDAMEDFDA UDI | Class I | Active |
| Dale Abdominal Binder | 820 | EUDAMEDFDA UDI | Class I | Active |
| Dale Transducer Holder | 622 | EUDAMEDFDA UDI | Class I | Active |
| Dale 241 PediPrints | 241 | EUDAMEDFDA UDI | Class I | Active |
| Hold-n-Place Legband | 316 | EUDAMEDFDA UDI | Class I | Active |
| Dale Abdominal Bunder | 818 | EUDAMEDFDA UDI | Class I | Active |
| Dale Post Surgical Compression Bra Size XX-Large | 715 | EUDAMEDFDA UDI | Class I | Active |
| Dale Abdominal Binder | 811 | EUDAMEDFDA UDI | Class I | Active |
| Dale Bendable Armboard | 650 | EUDAMEDFDA UDI | Class I | Active |
| Dale 280 Breezlock ET Tube Holder | 280 | EUDAMEDFDA UDI | Class I | Active |
| Dale Nasal Dressing Holder | 600 | EUDAMEDFDA UDI | Class I | Active |
| Dale Post Surgical Compression Bra Size Large | 713 | EUDAMEDFDA UDI | Class I | Active |
| Dale Abdominal Binder | 410 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Dale Medical Products, Inc. has four recall records listed in the FDA database, all initiated between September 27, 2007, and March 24, 2017, with each record marked as terminated. The reasons provided include issues with adhesive properties of ET Tube Holders, where the adhesive faceplate may fail to adhere to the patient’s face, and revised labeling instructions for a product, specifying that fastener hook tabs should not be trimmed to prevent disengagement at the trach plate.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 24, 2017 | Z-1927-2017 | — | terminated | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. |
| Mar 24, 2017 | Z-1928-2017 | — | terminated | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. |
| Sep 27, 2007 | Z-0447-2008 | — | terminated | Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate |
| Sep 27, 2007 | Z-0446-2008 | — | terminated | Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate |