120 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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Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LEH·April 30, 2007
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LEG·April 30, 2007
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr
FDA Recall
Terminated
·I-Flow Corporation·Product code FMF·August 1, 2008
B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide an optional filling device for the Easypump.
FDA Recall
Terminated
·I-Flow Corporation·Product code FMF·August 1, 2008
FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code LFL·November 25, 2003
HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LFL·March 16, 2012
Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.
FDA Recall
Terminated
·Integra LifeSciences Corp·Product code LFL·October 14, 2011
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
FDA Recall
Terminated
·Focus Diagnostics Inc·Product code LHL·February 15, 2017
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
Cytomics MXP Software, Version 1.0, Part No. 623688.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code GKL·February 13, 2004
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·November 28, 2005
LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September 1996 to present.
FDA Recall
Terminated
·Misonix, Inc·Product code LFL·August 13, 2003
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code GKL·June 26, 2013
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
FDA Recall
Terminated
·American Optisurgical Inc·Product code LFL·March 30, 2013
ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C35 and ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 45 cm Length Curved Jaw, Model # NSLG2C45. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LFL·January 26, 2012
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019