284 results
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17ms
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Sources: EU EUDAMED, US FDA
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Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·October 14, 2019
Mizuho OSI Modular Table System; Product Usage: For use in orthopaedic surgery to provide support to a patient.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code JEA·July 29, 2011
Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.
FDA Recall
Terminated
·Orthopedic Systems Inc·Product code FWZ·February 14, 2007
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
FDA Recall
Terminated
·Mizuho OSI·Product code GDC·December 14, 2015
Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code JEA·March 30, 2010
Coupler System II Mizuho Orthopedic Systems, Inc. Union City, CA 94587 The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc.
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code FWZ·February 27, 2012
OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code LHN·February 28, 2007
OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included)
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code LHN·February 28, 2007
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·December 17, 2012
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
FDA Recall
Open, Classified
·Mizuho OSI·Product code LXH·July 29, 2021
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.
FDA Recall
Terminated
·Mizuho OSI·Product code FWZ·March 28, 2017
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
FDA Recall
Open, Classified
·Mizuho OSI·Product code GDC·February 8, 2021
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·February 13, 2025
OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Orthopedic Systems, Inc., Union City, CA
FDA Recall
Terminated
·Mizuho Orthopedic Systems Inc·Product code JEA·February 28, 2007
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·October 22, 2024
E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology
FDA Recall
Terminated
·Kreg Medical Inc.·Product code OSI·August 2, 2012
Stryker MV3 bariatric bed, Part Number 5900000001
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code OSI·October 31, 2025
JK Bariatric Beds, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·January 2, 2019