84 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·August 15, 2018
***CAT#: 9297A***LINVATEC***Arthroscopic Blade***4.8mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 193794***Expiration Date: 10/2011. ***CAT #: 9299A***LINVATEC***Arthroscopic Blade***4.2mm GREAT WHITE, 13cm long***Qty: 6***Large Hub***White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 193534***Expiration Date: 10/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009
MAGNETOM Verio Nuclear magnetic resonance imaging
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LNH·January 10, 2011
Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE
FDA Recall
Terminated
·Biomet, Inc.·Product code HRX·February 10, 2011
Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE
FDA Recall
Terminated
·Biomet, Inc.·Product code HRX·February 10, 2011
syngo.plaza Image processing system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LLZ·September 21, 2011
Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KRI·August 12, 2011
NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test
FDA Recall
Terminated
·bioMerieux, Inc.·Product code OOI·May 10, 2011
UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
FDA Recall
Terminated
·Abbott Molecular·Product code JJH·October 11, 2011
Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FTL·May 10, 2011
Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code FST·October 10, 2011
syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.
FDA Recall
Terminated
·Siemens Medical Solutions, USA, Inc·Product code LLZ·May 10, 2011