32 results
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14ms
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Sources: EU EUDAMED, US FDA
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Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code OSN·December 13, 2017
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
FDA Recall
Terminated
·Medtronic·Product code FCG·February 8, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
FDA Recall
Terminated
·Medtronic·Product code FCG·February 8, 2017
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
FDA Enforcement
Class II
·Terminated·Vascutek, Ltd.·October 6, 2021
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·December 24, 2014
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.
FDA Recall
Terminated
·BSN Medical Inc·Product code FQM·February 1, 2022
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 Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code KGX·November 21, 2019
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).
FDA Recall
Terminated
·Sequent Medical Inc·Product code KRA·September 23, 2016
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·December 17, 2012
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 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
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
Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFR·April 3, 2008