28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3D GraftRasp System
FDA 510(k)
FDA Class 2
·General Hospital
KeyPrint
FDA UDI
Keystone Industries·H66842004311·KeyDenture Base Dark Veined 0.5kg
Intraoral Scan Body
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059075113·
LAHEY-SWEET HEMOSTATIC FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060876·LAHEY-SWEET HEMOSTATIC FORCEPS RIGHT ANGLED LON...
Pin
FDA UDI
Treace Medical Concepts, Inc.·00810111224888·Pin
FIBIOCORE
FDA 510(k)
FDA Class 1
·Dental
Neonatal Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·November 5, 2020
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 25, 2019
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 30, 2019
XIA II PA SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·December 2, 2010
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code CEO·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·January 16, 2015
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement Monitor - 55131 Alere INRatio 2 Replacement Monitor - 55128A Alere INRatio 2 PT/INR Professional Monitoring System The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
FDA Enforcement
Class I
·Terminated·Alere San Diego, Inc.·January 14, 2015
Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.
FDA Enforcement
Class I
·Terminated·Alere San Diego, Inc.·August 31, 2016
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code GJS·July 11, 2016