Is this your brand? Sign in to claim ownership.

MEDIVATORS INC.

United States·US-MF-000043422

Last updated September 17, 2026

Information

Country: United States
Address: 3150, Pollok Dr, Conroe, United States
Website: www.steris.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)444-4729
PRRC Contact: Zeeshan Shamim
EUDAMED SRN: US-MF-000043422
FDA FEI Number: 3003012447
DUNS Number: 068199363

Catalogue (5153)

Page 1 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4008275	FDA UDI	Class II	Active
FiberFlo	93022-101	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-949400-0004	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000984	FDA UDI	Class II	Active
Renaflo II Hemofilter	HF 700	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0018	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010570	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-660000-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009167	FDA UDI	Class II	Active
FiberFlo	93250-097	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010031	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009910	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200204-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006539	FDA UDI	Class II	Active
Custom Procedure Kit	4001425	FDA UDI	Class II	Active
Essential Kit	4000920	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103275-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101986	FDA UDI	Class II	Active
Custom Procedure Kit	4000294	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104191-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-430500-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104232-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-688020-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010692	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101884	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	100963	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4001452	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103966-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103539-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103966-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010539	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102878	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101367-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-533950-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-110450-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0001	FDA UDI	Class I	Unknown
Pentax irrigation pump	EGA-500P	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-109259-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010150	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009873	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-830105-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102659-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-105519-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104080-0001	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007895	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

STERIS Ireland Ltd IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (9)

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
Apr 20, 2021	Z-1859-2021	—	terminated	The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Oct 9, 2019	Z-1775-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1777-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1774-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1773-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1776-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1772-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1778-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Aug 3, 2015	Z-2761-2015	—	terminated	Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.