106 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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KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·October 3, 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 Enforcement
Class II
·Terminated·Stingray Surgical Products, LLC·July 25, 2012
Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·January 9, 2013
Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·January 9, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
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