31 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case; Manufactured by Medisav Services Inc. (MSI), 56 Elson Street, Markham, Ontario L3S 1Y7 Canada
FDA Recall
Terminated
·Elite Medical Group·Product code MPN--·July 3, 2003
OEC UroView 2800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016
OEC 9800, fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 31, 2016
ACL TOP 700 LAS, automated coagulation laboratory instrument.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·July 23, 2014
Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DKB·August 11, 2009
Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DLZ·August 11, 2009
The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.
FDA Recall
Terminated
·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011
RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
FDA Recall
Terminated
·PerkinElmer LAS Inc·Product code JBD·June 29, 2004
RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.
FDA Recall
Terminated
·PerkinElmer LAS Inc·Product code GKA·September 14, 2004
Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
FDA Recall
Terminated
·PerkinElmer LAS Inc·Product code JIA·September 8, 2004
International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220
FDA Recall
Terminated
·International Technidyne Corp.·Product code JKS·February 13, 2008
Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code KKS·July 25, 2006
G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
FDA Recall
Terminated
·Volk Optical Inc·Product code HKS·June 30, 2008
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 24, 2014
ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Enforcement
Class II
·Terminated·Instrumentation Laboratory Co.·September 25, 2013
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·July 8, 2015