Data / Medical devices / United States / Dale Medical Products, Inc.
Dale Medical Products, Inc.: FDA-registered device maker in New London, CT, United States, 1 510(k) clearance
Dale Medical Products, Inc. is registered with the FDA (registration 1214422) in New London, CT, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 30, 2008. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1214422
- Address
- 3 State Pier Rd, New London, CT, United States, 06320
- Owner or operator
- DALE MEDICAL PRODUCTS, INC. (1214422)
- Roles
- Manufacturer
- First device listed
- January 4, 1993
- Registered through
- 2026
- Brand names listed
- DALE ABDOMINAL BINDER, DALE ABDOMINAL FOLEY CATHETER HOLDER, DALE BENDABLE ARMBOARD, DALE BREEZELOCK ENDOTRACHEAL TUBE HOLDER, DALE HOLD-N-PLACE FOLEY CATHETER HOLDER, DALE IV LINE MANAGER, DALE IV-ARMOR, DALE LEGBAND FOLEY CATHETER HOLDER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Administration Set Securement Device | PUK | 1 | Manufacturer | accessdata.fda.gov |
| Binder, Abdominal | FSD | 1 | Manufacturer | accessdata.fda.gov |
| Binder, Breast | HEF | 1 | Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Manufacturer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Manufacturer | accessdata.fda.gov |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | 1 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 30, 2008 | K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 | KNT | Substantially Equivalent | Dale Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 24, 2017 | 76965 | Class II | Terminated | Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's sk | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. | accessdata.fda.gov |
| September 27, 2007 | 45460 | Not yet classified | Terminated | Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical Products, Inc., Plainville, MA 02762 | Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate | accessdata.fda.gov |
Compare with other makers
- All makers of Binder, Breast
- All makers of Splint, Extremity, Noninflatable, External, Sterile
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Holder, Ureteral Catheter
- All makers of Binder, Abdominal
- All makers of Device, Fixation, Tracheal Tube
Updated October 30, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.