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

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Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

FDA Enforcement
Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

FDA Enforcement
Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

FDA Enforcement
Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

FDA Enforcement
Class II ·Terminated·Mizuho OSI·February 20, 2013

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 Enforcement
Class II ·Terminated·Mizuho OSI·February 17, 2016

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 Enforcement
Class II ·Terminated·Mizuho OSI·April 26, 2017

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 Enforcement
Class II ·Terminated·Mizuho OSI·October 21, 2020

3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

FDA Enforcement
Class II ·Terminated·3M Company/3m Espe Dental Products·September 4, 2013