Company
Pro-Dex Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2024 | Pro-Dex Inc KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000 Open, Classified |
MOQ | None listed |
| Jul 5, 2023 | Pro-Dex Inc KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver Open, Classified |
GEY | None listed |
| Apr 14, 2023 | Pro-Dex Inc KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2
E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter. Open, Classified |
GET | None listed |
| Sep 25, 2018 | Pro-Dex Inc PRO-DEX Surgical Driver Battery Pack PDBP-001 Series
PRO-DEX Battery Pack, Single Pouch - PDBP-001-2
PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2
Product Usage:
-The PDBP-001 Battery is a single use Terminated |
GEY | None listed |
| Mar 11, 2016 | Pro-Dex Inc Battery Pack
KLS-SD-1000
Single
Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver). Terminated |
MOQ | None listed |
| Mar 11, 2016 | Pro-Dex Inc Battery Pack
KLS-SD-1000
Case (40 ct)
Models: KLS-BP-040
Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver). Terminated |
MOQ | None listed |