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Creo Medical, Ltd.

Last updated May 24, 2026

Information

Device	Model / Reference	Registries	Class	Status
Speedboat RS2 8 Fr Instrument	7-RS2-003	FDA UDI	Class II	Active
Reusable Interface Cable, 1.5 m	PRD-IFC-002	FDA UDI	Class II	Active
Croma Generator	7-EMR-050 V6.001	FDA UDI	Class II	Active
Creo Medical	7-RS2-001	FDA UDI	Class II	Active
Speedboat Notch Long	PRD-SB1-003	FDA UDI	Class II	Active
Croma	Croma Generator V4.0	FDA UDI	Class II	Active
MicroBlate Fine	7-NP1-100	FDA UDI	Class II	Active
SpydrBlade Flex	PRD-RG1-001	FDA UDI	Class II	Active
Creo Medical	Generator 7-EMR-050	FDA UDI	Class II	Unknown
Creo Medical	Generator 7-EMR-050 with Footswitch 2-EMR-050	FDA UDI	Class II	Unknown
Croma	Slypseal Flex	FDA UDI	Class II	Active
Speedboat Ultraslim (SB1L) Electrosurgical Instrument	Speedboat Ultraslim Long (SB1L)	FDA UDI	Class II	Active
Microblate Flex	AB1 Instrument	FDA UDI	Class II	Active
Croma Generator	7-EMR-050 V6.01	FDA UDI	Class II	Active
Creo Electrosurgical System with NP1 Instrument	K221672	FDA 510(k)	Class II	Active
AB1 Electrosurgical Instrument, Creo Electrosurgical System	K223138	FDA 510(k)	Class II	Active
Reusable Interface Cable 1.5 m (PRD-IFC-002)	K242061	FDA 510(k)	Class II	Active
NP1 Instrument, Creo Electrosurgical System	K200003	FDA 510(k)	Class II	Active
ABI Instrument, Creo Electrosurgical System	K200298	FDA 510(k)	Class II	Active
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory	K171983	FDA 510(k)	Class II	Active
Creo Electrosurgical System with HS1 Hemostasis Accessory	K192905	FDA 510(k)	Class II	Active
Speedboat Flush SB1 Instrument	K230328	FDA 510(k)	Class II	Active

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