29 results
·
28ms
·
Sources: EU EUDAMED, US FDA
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Safco DENTA-SAFE NON-LATEX DENTAL DAM
FDA UDI
SAFCO DENTAL SUPPLY CO.·20810063750163·Heavy (0.23mm-0.28mm thickness) 6" x 6", green,...
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496020783·RELAX UNISEX 70, SIZE L, BORDEAUX, GRADUATED CO...
iDock51 Audio/Video Extend Module
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904095547·
iDock51 Audio/Video Extend Module
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904048970·
DIRECT TIBC CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FIXION INTERLOCKING NAIL (FIXION IL NAIL)
FDA 510(k)
FDA Class 2
·Orthopedic
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 17, 2018
ZILVER BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·March 5, 2020
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 26, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013
RENEGADE HI-FLO MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·March 16, 2011
*
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·March 17, 2008
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017