Clip, Scalp (HBO): 16 FDA-registered makers in 3 countries

Name: FDA-registered makers of Clip, Scalp
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

16 establishments in 3 countries are registered with the FDA to make Clip, Scalp (product code HBO, Class 2, 21 CFR 882.4150). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on July 21, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: HBO
Device class: 2
Regulation: 882.4150
Medical specialty: Neurology

Makers by country

Country	Makers
United States	11
Mexico	3
Germany	2

Makers of Clip, Scalp

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	2	July 31, 2001	0	api.fda.gov
Medtronic Neurosurgery	Fort Worth, TX, United States	Specification developer	2	February 7, 2005	2	api.fda.gov
Acra Cut, Inc.	Acton, MA, United States	Manufacturer	1	November 18, 1994	0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	1	January 7, 2004	0	api.fda.gov
Integra LifeSciences Production Corporation	Mansfield, MA, United States	Manufacturer, Specification developer	1	February 21, 1991	0	api.fda.gov
Rudolf Storz GMBH	EMMINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	1	January 7, 2004	0	api.fda.gov
Apex Resource Technologies, Inc., PPC Industries, A Spectrum Plastics Group Co.	Pittsfield, MA, United States	Contract manufacturer	0		0	api.fda.gov
Classic Industries, Inc.	Latrobe, PA, United States	Contract manufacturer	0		0	api.fda.gov
Coastline de Mexico SA de CV	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0		0	api.fda.gov
Integra Pain Management	West Valley City, UT, United States	Manufacturer	0		0	api.fda.gov
Phoenix Instruments, Inc.	Lisle, IL, United States	Contract manufacturer	0		0	api.fda.gov
PMC SMART Solutions, LLC	Shelbyville, IN, United States	Contract manufacturer	0		0	api.fda.gov
Teleflex LLC (NADC)	Olive Branch, MS, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Teleflex Medical LLC	Morrisville, NC, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, Mexico	Manufacturer	0		0	api.fda.gov

Updated July 21, 2026. 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.