103 results
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29ms
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Sources: EU EUDAMED, US FDA
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PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
FDA Recall
Terminated
·Materialise USA LLC·Product code JWH·March 23, 2012
PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID--0242-LF Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
FDA Recall
Terminated
·Materialise USA LLC·Product code JWH·March 23, 2012
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.
FDA Recall
Terminated
·Stingray Surgical Products, LLC·Product code GEI·May 23, 2012
Sorin C5 (perfusion system) The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DTQ·February 23, 2012
S5 Single Roller Pump 150 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DTQ·February 23, 2012
S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DTQ·February 23, 2012
Control panel for mast roller pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DTQ·February 23, 2012
Control panel for mast roller pump 150/85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DTQ·February 23, 2012
Pump control panel. The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DWA·February 23, 2012
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code OYT·April 23, 2012
RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)
FDA Recall
Terminated
·Optovue Inc.·Product code OBO·February 21, 2012
Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code MUI·March 2, 2012
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
FDA Recall
Terminated
·Sigma·Product code FRN·April 23, 2012
Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code MUI·March 2, 2012
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZL·January 23, 2012
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·May 23, 2012
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·April 23, 2012
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
FDA Recall
Terminated
·Perkinelmer·November 26, 2012
Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FRN·March 23, 2012
LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision.
FDA Recall
Terminated
·Stryker Spine·Product code GAD·April 23, 2012