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KIRWAN SURGICAL PRODUCTS LLC

United States·US-MF-000008222

Last updated May 26, 2026

Information

Country: United States
Address: 180, Enterprise Drive, Marshfield, United States
Website: www.ksp.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 781-834-9500
PRRC Contact: Linda Varroso
EUDAMED SRN: US-MF-000008222
FDA FEI Number: —
DUNS Number: 046355210

Catalogue (2076)

Page 1 of 42

Device	Model / Reference	Registries	Class	Status
Maxmorespine	1001-BE 013	EUDAMED	Class IIb	Active
Kirwan	12-1436AUS	FDA UDI	Class II	Active
Kirwan	26-2520S	FDA UDI	Class II	Active
Kirwan	20-1419AUS	FDA UDI	Class II	Active
Kirwan	23-1415AUS	FDA UDI	Class II	Active
Kirwan	12-1438AUS	FDA UDI	Class II	Active
Kirwan	10-6000VS	FDA UDI	Class II	Active
Kirwan	19-5044AUX	FDA UDI	Class II	Unknown
Kirwan	10-6050S	FDA UDI	Class II	Active
Kirwan	19-1003C	FDA UDI	Class II	Active
Kirwan	26-2520	FDA UDI	Class II	Active
Kirwan	18-1100	FDA UDI	Class II	Active
Kirwan	12-1633AUS	FDA UDI	Class II	Active
Kirwan	20-1110AU	FDA UDI	Class II	Active
Kirwan	30-3010	FDA UDI	Class I	Active
Kirwan	19-1290C	FDA UDI	Class II	Active
Kirwan	21-1415AUS	FDA UDI	Class II	Active
Kirwan	11-50202	FDA UDI	Class II	Active
Kirwan	10-5604AUS	FDA UDI	Class II	Active
Kirwan	15-5402AUS	FDA UDI	Class II	Active
Kirwan	19-5046AUIR	FDA UDI	Class II	Unknown
Kirwan	10-1413AUS	FDA UDI	Class II	Active
Kirwan	22-1432PLS	FDA UDI	Class II	Active
Kirwan	10-1403AUS	FDA UDI	Class II	Active
Kirwan	10-2404AUS	FDA UDI	Class II	Active
Kirwan	12-1400AUS	FDA UDI	Class II	Active
Kirwan	10-3402AUS	FDA UDI	Class II	Active
Kirwan	10-4001A	FDA UDI	Class II	Active
Kirwan	20-1614AUS	FDA UDI	Class II	Active
Kirwan	20-1418EAUS	FDA UDI	Class II	Active
Kirwan	20-1616AUS	FDA UDI	Class II	Active
Kirwan	30-2008S	FDA UDI	Class II	Active
Kirwan	12-1633AUS	FDA UDI	Class II	Active
Kirwan	12-5108AUS	FDA UDI	Class II	Active
Kirwan	12-1435AUS	FDA UDI	Class II	Active
Kirwan	24-1445AUS	FDA UDI	Class II	Active
Kirwan	21-1419AUS	FDA UDI	Class II	Active
Kirwan	10-6000S	FDA UDI	Class II	Active
Kirwan	10-2402AUS	FDA UDI	Class II	Active
Kirwan	50-1002	FDA UDI	Class I	Active
Kirwan	12-1435AUS	FDA UDI	Class II	Active
Kirwan	12-1434AUS	FDA UDI	Class II	Active
Kirwan	20-1412AUS	FDA UDI	Class II	Active
Kirwan	10-6002	FDA UDI	Class II	Active
Kirwan	24-1458AUS	FDA UDI	Class II	Active
Kirwan	12-1634AUS	FDA UDI	Class II	Active
Kirwan	30-1204	FDA UDI	Class II	Active
Kirwan	20-1621AUS	FDA UDI	Class II	Active
Kirwan	10-5601NSS	FDA UDI	Class II	Active
Kirwan	10-6050S	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MPS Medical Product Service GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

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
Nov 14, 2024	Z-0659-2025	—	open, classified	Potential for the outer stainless-steel tube to break or detach.
Nov 14, 2024	Z-0655-2025	—	open, classified	Potential for the outer stainless-steel tube to break or detach.
Nov 14, 2024	Z-0658-2025	—	open, classified	Potential for the outer stainless-steel tube to break or detach.
Nov 14, 2024	Z-0657-2025	—	open, classified	Potential for the outer stainless-steel tube to break or detach.
Nov 14, 2024	Z-0656-2025	—	open, classified	Potential for the outer stainless-steel tube to break or detach.
Nov 14, 2024	Z-0660-2025	—	open, classified	Potential for the outer stainless-steel tube to break or detach.
Nov 14, 2024	Z-0654-2025	—	open, classified	Potential for the outer stainless-steel tube to break or detach.