Data / Medical devices / United States / ICU Medical, Inc.
ICU Medical, Inc.: FDA-registered device maker in Highland, IN, United States, 11 510(k) clearances
ICU Medical, Inc. is registered with the FDA (registration 3027579175) in Highland, IN, United States. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 12, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027579175
- Address
- 2625 Main St, Highland, IN, United States, 46322
- Owner or operator
- ICU Medical, Inc. (8020727)
- Roles
- Manufacturer
- First device listed
- October 2, 1992
- Registered through
- 2026
- Brand names listed
- Adapter, BIVONA, Bivona Adjustable Hyperflex, Bivona Disconnect Wedge, Bivona Hyperflex, Bivona® Aire-Cuf® Neonatal and Pediatric Tracheostomy Tubes, Bivona® Aire-Cuf® Tracheostomy Tubes, Bivona® Cuff Maintenance Device (CMD¿)open and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Tube Tracheostomy And Tube Cuff | JOH | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheostomy (W/Wo Connector) | BTO | 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 |
|---|---|---|---|---|---|---|
| September 12, 2008 | K081440 | BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| October 27, 1994 | K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| December 29, 1992 | K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| January 30, 1992 | K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| October 23, 1991 | K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| October 23, 1991 | K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| August 9, 1991 | K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| July 17, 1991 | K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. | JOH | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| June 19, 1991 | K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| November 2, 1988 | K884427 | FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. | BTO | Substantially Equivalent | Bivona Medical Technologies | accessdata.fda.gov |
| September 21, 1981 | K812163 | AIRE-CUF TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Bioana Surgical Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Tracheostomy (W/Wo Connector)
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Connector, Airway (Extension)
Updated September 12, 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.