Acuderm, Inc.
Fort Lauderdale, FL, US
ACUDERM, INC. appears in FDA device records in Fort Lauderdale, FL. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Acuderm, Inc. between 1983 and 1994. The busiest year on record is 1983, with 4. The most recent is 1994, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 4 |
| 1986 | 1 |
| 1987 | 1 |
| 1989 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K933516 | ACU-E PUNCH | LRY | Substantially Equivalent | |
| K933265 | ACU-DISPO-CE(TM) | MDM | Substantially Equivalent | |
| K933137 | ACU-SUTURE KIT | LRO | Substantially Equivalent | |
| K930043 | ACU-EVAC | FYD | Substantially Equivalent | |
| K933866 | ACU-HEMOSTATIC RING | MDM | Substantially Equivalent | |
| K915000 | ACU-GUARD | GEX | Substantially Equivalent | |
| K891334 | ACU-CURETTE | FZS | Substantially Equivalent | |
| K874024 | ACU-MICRO-NEEDLE | FMI | Substantially Equivalent | |
| K854877 | ACU-SYRINGE W/WO NEEDLES | FMF | Substantially Equivalent | |
| K832583 | SABOURAUD DEXTROSE AGAR | JSJ | Substantially Equivalent | |
| K832582 | MYCOSEL AGAR | JSJ | Substantially Equivalent | |
| K832581 | DTM-DERMATOPHYTE TEST MEDIUM | JSJ | Substantially Equivalent | |
| K831635 | ACU-PUNCH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1035236 | 1035236 | ACUDERM, INC. | 6555 Powerline Road, FORT LAUDERDALE, FL 33309 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYDApparatus, Exhaust, Surgical
- JSJCulture Media, Selective And Non-Differential
- FZSCurette, Surgical, General Use
- LROGeneral Surgery Tray
- MDMInstrument, Manual, Surgical, General Use
- KDDKit, Surgical Instrument, Disposable
- FMINeedle, Hypodermic, Single Lumen
- GEXPowered Laser Surgical Instrument
- LRYPunch, Surgical
- LRWScissors, General, Surgical
- FMFSyringe, Piston
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain