90 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Enforcement
Class III
·Terminated·Randox Laboratories, Limited·August 14, 2019
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
FDA Enforcement
Class II
·Terminated·Clark Laboratories, Inc.·May 5, 2021
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
FDA Enforcement
Class III
·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·October 3, 2012
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
FDA Enforcement
Class II
·Terminated·NeuroLogica Corporation·November 18, 2015
Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only difference between the models is in color. Model 102 040 is yellow, Model 102 020 is beige and Model 102 030 is red. )
FDA Recall
Terminated
·Product code MMK·February 25, 2004
Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 7, 2017
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
FDA Enforcement
Class III
·Terminated·Lab Vision Corporation·February 24, 2016
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.
FDA Enforcement
Class II
·Terminated·Spectranetics Corp.·February 17, 2016
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
FDA Recall
Terminated
·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GQX·May 29, 2012
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
FDA Recall
Terminated
·NeuroLogica Corporation·Product code IZI·September 14, 2015
Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbiological culture media, where it is generally used to replace infusion of meat. Culture media containing Beef Extract Powder are recommended for use in bacteriological examination of water, milk, and other materials, where uniform composition of media is important. Beef Extract Powder is relied upon for biochemical studies, particularly fermentation reactions because of its independence from ferment-able substances. Several media containing Beef Extract Powder are recommended in standard methods for multiple application.
FDA Recall
Terminated
·Acumedia Manufacturers, Inc.·Product code JSK·September 11, 2015
XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code muj·May 13, 2009
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·June 10, 2019
SoftWeb version 4.0.4.10.1. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. Manufacture Date: 05/16/2006.
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·June 8, 2006
ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany
FDA Recall
Terminated
·Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany·Product code JAI·June 2, 2006
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code GFJ·November 11, 2019
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
FDA Recall
Terminated
·Clark Laboratories, Inc.·Product code PCL·March 17, 2021
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code DQK·July 24, 2020
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
FDA Recall
Terminated
·Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany·Product code ISY·July 16, 2015