Intl. Medical Industries
Pompano Beach, FL, US
INTL. MEDICAL INDUSTRIES appears in FDA device records in Pompano Beach, FL. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Intl. Medical Industries carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- International Medical Industries, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for Intl. Medical Industries between 1985 and 2024. The busiest year on record is 1986, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231095 | Tamper Evident Cap | FMF | Substantially Equivalent | |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | QEH | Substantially Equivalent | |
| K193192 | Tamper Evident Cap | FMF | Substantially Equivalent | |
| K190305 | Additive Cap | KPE | Substantially Equivalent | |
| K182545 | Tamper Evident Cap with Male Luer Lock | FPA | Substantially Equivalent | |
| K173577 | Guarded Luer Connector | LHI | Substantially Equivalent | |
| K170672 | Tamper Evident Cap For use with ENFit Syringes | PNR | Substantially Equivalent | |
| K861276 | TAMPER PROOF CAP | FMF | Substantially Equivalent | |
| K860434 | CHEMO-VENT | LHI | Substantially Equivalent | |
| K850051 | VERSA-FILL 120 & FILL SET 42-50 | LHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1217831 | 1217831 | INTL. MEDICAL INDUSTRIES | 2981 Gateway Drive, POMPANO BEACH, FL 33069 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MJFCheck Valve, Retrograde Flow (In-Line)
- KPEContainer, I.V.
- KYXDispenser, Liquid Medication
- PNREnteral Syringes With Enteral Specific Connectors
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FMFSyringe, Piston
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0925-2023 | 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 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile; d. Part number 57-402, Female Slip - Female Lock Guarded Luer Connector, Sterile; and e. Part number 57-403, Female Slip - Female Slip Guarded Luer Connector. | Blister package had an unsealed edge compromising sterility. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain