44 results
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37ms
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Sources: EU EUDAMED, US FDA
HANUL BIO
FDA registration
HANUL BIO·1 product·🇰🇷 South Korea
VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·July 3, 2013
REPLACEMENT HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·February 19, 2011
BIO-TENODESIS SCREW WITH HANDLE INSERTER, 3X8MM
FDA Adverse Event
Other
·ARTHREX, INC.·Product code HWC·July 10, 2009
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 23, 2020
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LOM·July 27, 2012
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·March 21, 2012
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·May 6, 2014
BIO-COMP TENODESIS SCREW W/HANDLED INSERTER 3X8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·August 19, 2011
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·March 3, 2011
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·August 27, 2014
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·August 27, 2014
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·July 18, 2013
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·April 14, 2022
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWS·November 25, 2020
PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via ethernet hub. The computer provides worklist generation, data management, data reduction and microplate reader control functions.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code JQW·September 29, 2009
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3MM X 8MM
FDA Adverse Event
Other
·ARTHREX, INC.·Product code HWC·June 8, 2007
BIO-TENODESIS SCREW WITH HANDLE INSERTER, 3 X 8MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·December 18, 2009
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3MM X 8MM
FDA Adverse Event
Other
·ARTHREX, INC.·Product code MBI·September 7, 2007
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3MM X 8MM
FDA Adverse Event
Other
·ARTHREX, INC.·Product code MBI·September 7, 2007