Data / Medical devices / United States / Intl. Medical Industries
Intl. Medical Industries: FDA-registered device maker in Pompano Beach, FL, United States, 7 510(k) clearances
Intl. Medical Industries is registered with the FDA (registration 1217831) in Pompano Beach, FL, United States. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 4, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1217831
- Address
- 2981 Gateway Drive, Pompano Beach, FL, United States, 33069
- Owner or operator
- International Medical Industries, Inc. (1217831)
- Roles
- Manufacturer
- First device listed
- August 10, 2004
- Registered through
- 2026
- Brand names listed
- Additive Port Cap, Aspirating Needles, Check Valve, Enteral Tamper Evident Cap, Filtered Venting Needle, Guarded Luer Connector, Luer Lock Caps, Male Tamper Evident Cap and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Check Valve, Retrograde Flow (In-Line) | MJF | 2 | Manufacturer | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | QEH | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 4, 2024 | K231095 | Tamper Evident Cap | FMF | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| December 16, 2020 | K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | QEH | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| April 30, 2019 | K190305 | Additive Cap | KPE | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182545 | Tamper Evident Cap with Male Luer Lock | FPA | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| June 7, 2018 | K173577 | Guarded Luer Connector | LHI | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| October 6, 2017 | K170672 | Tamper Evident Cap For use with ENFit Syringes | PNR | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| February 12, 1986 | K860434 | CHEMO-VENT | LHI | Substantially Equivalent | Intl. Medical Industries | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2022 | 91276 | Class II | Ongoing | Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number | Blister package had an unsealed edge compromising sterility. | accessdata.fda.gov |
Compare with other makers
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Dispenser, Liquid Medication
- All makers of Container, I.V.
Updated September 4, 2024. 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.