16 results · 6ms · Sources: EU EUDAMED, US FDA

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Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666

FDA Enforcement
Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH

FDA Enforcement
Class II ·Ongoing·Ethicon Endo Surgery, LLC·April 9, 2025

Female Fertility Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Enforcement
Class II ·Ongoing·Shimadzu Medical Systems·December 16, 2020

Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·February 4, 2026

Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·March 25, 2026

Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.

FDA Enforcement
Class II ·Ongoing·B BRAUN MEDICAL INC·October 15, 2025

Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022

Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·June 23, 2021

Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size

FDA Enforcement
Class II ·Terminated·Skytron, Div. The KMW Group, Inc·June 8, 2016

EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table

FDA Enforcement
Class II ·Terminated·Skytron, Div. The KMW Group, Inc·June 8, 2016

Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms

FDA Enforcement
Class II ·Terminated·Skytron, Div. The KMW Group, Inc·January 20, 2016

Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

FDA Enforcement
Class II ·Terminated·Skytron, Div. The KMW Group, Inc·June 19, 2019

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020

SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.

FDA Enforcement
Class II ·Terminated·Skytron, Div. The KMW Group, Inc·October 21, 2020

VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.

FDA Enforcement
Class II ·Terminated·Skytron, Div. The KMW Group, Inc·October 14, 2020