Data / Medical devices / United States / Pro-Dex, Inc.
Pro-Dex, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Pro-Dex, Inc. is registered with the FDA (registration 2081135) in Irvine, CA, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2002. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2081135
- Address
- 2361 McGaw Avenue, Irvine, CA, United States, 92614
- Owner or operator
- PRO-DEX, INC. (2081135)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 23, 1992
- Registered through
- 2026
- Brand names listed
- Atlas Pro Driver (APD-1000-1), Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1), Atlas Pro Driver Hex Collet (APD-CA-001-1), Dynatip P/N 3293 Tip, Cover / Protector, PDCMF Driver (PDCMF-1000-X), PDCMF Power Driver (PDCMF-1000-X), Pro-Dex Surgical Driver (PDSD-5000-X), Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBD-040-X) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Contract manufacturer | accessdata.fda.gov |
| Bit, Surgical | GFG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screwdriver, Skullplate | GXL | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 2, 2002 | K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | KCT | Substantially Equivalent | Symmetry Medical, Inc. | 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 23, 2024 | 95510 | Class II | Ongoing | 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 | The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package. | accessdata.fda.gov |
| February 15, 2023 | 92493 | Class II | Ongoing | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver | Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired. | accessdata.fda.gov |
| February 14, 2023 | 91850 | Class II | Ongoing | 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. | Incorrect Unique Device Identifier/GTIN code was used on product. | accessdata.fda.gov |
| September 25, 2018 | 83113 | Class II | Terminated | 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 (non-rechargeable) s | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. | accessdata.fda.gov |
| December 23, 2015 | 73034 | Class II | Terminated | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver). | The sterile battery may contain particulates within the sterile package. | accessdata.fda.gov |
| January 19, 2009 | 53430 | Not yet classified | Terminated | Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants. | Pro-Dex has initiated a recall on their Dental Torque Wrench. The recall was initiated due to an inaccurate laser etch identification of the torque value. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Bit, Surgical
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Screwdriver, Skullplate
- All makers of Motor, Surgical Instrument, Ac-Powered
- All makers of Orthopedic Stereotaxic Instrument
Updated October 31, 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.