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Bolder Surgical

United States Last updated 21 Oct 2026

Devices
7
Registries
EUDAMEDFDA 510(k)GUDID
FDA recalls
1

Catalogue7

Related companies

Authorised representatives

FDA recalls1

Device pages show only the recalls that name the device or its 510(k)/PMA.

  • 2022

    • 25 Jan 2022 Z-0736-2022 Class II Terminated A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.

About

Hologic is a global medical technology company primarily focused on improving women's health through innovative diagnostics, medical imaging systems, and surgical products.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Bolder Surgical have in the registry?

The registry currently lists 7 devices for Bolder Surgical. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bolder Surgical's devices?

Among its 7 most recently registered devices, Bolder Surgical has devices listed in EUDAMED (2 devices), FDA 510(k) (5 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Bolder Surgical's devices fall under?

Among its 7 most recently registered devices, the classes recorded for Bolder Surgical's devices are Class IIb and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Bolder Surgical?

FDA recall records list 1 recall initiated by Bolder Surgical, the most recent initiated on 2022-01-25. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Bolder Surgical in the registry?

The most recently registered devices listed for Bolder Surgical include CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft), CoolSeal Reveal, CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 and CoolSeal Trinity.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
331, S 104th St, Louisville, United States
Phone
+1 800 442 9892
PRRC contact
David Ramsay
EUDAMED SRN
US-MF-000008575