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PRO-DEX, INC.

United States·US-MF-000010685

Last updated September 17, 2026

Information

Country: United States
Address: 2361 McGaw Ave, Irvine, United States
Website: www.pro-dex.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 949-769-3200
PRRC Contact: Angel Domingo
EUDAMED SRN: US-MF-000010685
FDA FEI Number: 2081135
DUNS Number: 849370358

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
MatrixPRO II Handpiece Loaner	05.000.030LN	FDA UDI	Class I	Active
Zimmer Biomet 90D Atlas Blade	APD-B90-201	FDA UDI	Class I	Active
Battery Pack, Kls-Sd-1000, Single	KLS-BP-001	FDA UDI	Class I	Active
Zimmer Biomet Atlas Pro Driver	APD-1000-4	FDA UDI	Class I	Active
KLS Martin Surgical Driver, Non-Torque Limiting	KLS-SD-1000-NTL	FDA UDI	Class I	Active
Kls Martin Surgical Driver	KLS-SD-1000	FDA UDI	Class I	Active
KLS E-Coupling Adapter	PDEC-1000-2	FDA UDI	Class I	Active
Atlas Pro Driver Sterilization Case	APD-SC-001	FDA UDI	Class II	Active
MatrixPRO Driver Loaner	05.000.020LN	FDA UDI	Class I	Active
Zimmer Biomet Atlas Pro Driver Sterilization Container	APD-SC-003	FDA UDI	Class II	Active
Zimmer Biomet 90D Collet	APD-CA-301	FDA UDI	Class I	Active
KLS E-Coupling Adapter	PDEC-1000-3	FDA UDI	Class I	Active
Zimmer Biomet Atlas Pro-Driver Battery, Single Use	APD-BP-001S-4	FDA UDI	Class I	Active
KLS MaxDriver 2	KLS-SD-2000	FDA UDI	Class I	Active
Atlas Pro Driver Collet Attachment Hex	APD-CA-001-1	FDA UDI	Class I	Active
Zimmer Biomet Straight Collet	APD-CA-005	FDA UDI	Class I	Active
Atlas Pro Driver Battery Pack, Sterile	APD-BP-001S-1	FDA UDI	Class I	Active
Battery Pack, Kls-Sd-2000, Single	KLS-BP2-001	FDA UDI	Class I	Active
Sterilization Case, PDCMF (AXS™ NEURO DRIVER Storage and Transport Tray)	PDCMF-SC-001	FDA UDI	Class I	Active
Atlas Pro Driver	APD-1000-1	FDA UDI	Class I	Active
Battery Pack, Single Use, PDCMF, Tadiran	PDCMF-BP-001	FDA UDI	Class I	Active
Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)	PDCMF-1000-1	FDA UDI	Class I	Active
PRO-DEX Surgical Driver	PDSD-5000-5	EUDAMEDFDA UDI	Class IIa	Active
MatrixPRO II Driver	05.000.030	EUDAMEDFDA UDI	Class IIa	Active
PRO-DEX Surgical Driver	PDSD-5000-1	EUDAMEDFDA UDI	Class IIa	Active
MatrixPRO Driver Battery, Sterile	05.000.021S	EUDAMEDFDA UDI	Class I	Active
PRO-DEX Surgical Driver	PDSD-5000-6	EUDAMEDFDA UDI	Class IIa	Active
PRO-DEX Surgical Driver	PDSD-5000-2	EUDAMEDFDA UDI	Class IIa	Active
MatrixPRO Driver	05.000.020	EUDAMEDFDA UDI	Class IIa	Active
MatrixPRO II 90-Degree Collet, Short	03.000.502	EUDAMEDFDA UDI	Class IIa	Active
PRO-DEX Battery Pack	PDBP-001-2	EUDAMEDFDA UDI	Class I	Active
MatrixPRO II J-Latch Collet	03.000.501	EUDAMEDFDA UDI	Class IIa	Active
MatrixPRO II 90-Degree Collet, Long	03.000.503	EUDAMEDFDA UDI	Class I	Active
MatrixPRO II Single Use Battery	05.000.031S	EUDAMEDFDA UDI	Class I	Active
MatrixPRO Driver Graphic Case	60.000.010	EUDAMEDFDA UDI	Class I	Active
MatrixPRO Driver Graphic Case Replacement Lid	60.000.011	EUDAMEDFDA UDI	Class I	Active
MatrixPRO II Hex Collet	03.000.500	EUDAMEDFDA UDI	Class IIa	Active
MatrixPRO II Graphic Case	60.000.015	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Eurolink Europe Compliance Limited IE

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Authorities

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 23, 2024	Z-0280-2025	—	open, classified	The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Feb 15, 2023	Z-2098-2023	—	open, classified	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.
Feb 14, 2023	Z-1391-2023	—	open, classified	Incorrect Unique Device Identifier/GTIN code was used on product.
Sep 25, 2018	Z-2340-2019	—	terminated	Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Dec 23, 2015	Z-1094-2016	—	terminated	The sterile battery may contain particulates within the sterile package.
Dec 23, 2015	Z-1095-2016	—	terminated	The sterile battery may contain particulates within the sterile package.