11 results
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14ms
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Sources: EU EUDAMED, US FDA
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
FDA Enforcement
Class I
·Terminated·TELEFLEX-MORRISVILLE·November 13, 2019
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
FDA Enforcement
Class I
·Terminated·Galemed Corporation·January 1, 2020
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
FDA Enforcement
Class II
·Terminated·Clerio Vision·April 14, 2021
Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
FDA Enforcement
Class II
·Terminated·Clerio Vision·January 20, 2021
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
FDA Enforcement
Class II
·Terminated·NEOSTEO·August 18, 2021
Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·December 26, 2018
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
FDA Enforcement
Class II
·Terminated·Hans Pausch Rontgengeratebau Gmbh·June 7, 2017
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021
Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.
FDA Enforcement
Class II
·Terminated·Maytex Corp·June 12, 2013