Dale Medical Products, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 13
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1928-2017 | Class II | Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal T | March 24, 2017 |
| Z-1927-2017 | Class II | Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tub | March 24, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K082241 | THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 | October 30, 2008 |
| K994300 | NASOGASTRIC TUBE HOLDER, MODEL 160 | February 10, 2000 |
| K964399 | DALE ENDOTRACHEAL TUBE HOLDER 270/280 | January 28, 1997 |
| K961693 | DALE GASTROSTOMY TUBE HOLDER | July 30, 1996 |
| K951491 | DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS | April 24, 1995 |
| K914245 | DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) | December 9, 1991 |
| K905231 | DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. | January 14, 1991 |
| K894586 | DALE I.V. IDENTIFIER; PRODUCT #1125 | August 15, 1989 |
| K873311 | DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 | November 5, 1987 |
| K864897 | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 | January 12, 1987 |
| K860583 | DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 | February 21, 1986 |
| K832946 | DALE ENDOTRACHEAL TUBE HOLDER | October 14, 1983 |
| K812429 | DALE COMBO TRACHEOSTOMY TUBE HOLDER | September 23, 1981 |