28 results
·
36ms
·
Sources: EU EUDAMED, US FDA
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540602573·Bone Screws, MP, Cross-Pin
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221231390·Unitek Miniature Twin MBT UR Bi -7T/0A DHk 022 MMT
CURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm OD
FDA UDI
ORTHO OUTCOMES, LLC·00850072364131·CURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm OD
M6-C
FDA UDI
Spinal Kinetics, Inc.·00812388031213·Fin Cutter, 7LL (7mm H x 17mm W x 16mm D), G7
APPLICATOR TIP/DUAL SPRAYER KIT
FDA 510(k)
FDA Class 2
·General Hospital
KAVO CORUND HANDPIECE 2013
FDA 510(k)
FDA Class 2
·Dental
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
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 30, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 1, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 15, 2013
VISION HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011
OXFORD UNI TIB TRAY 41X26 RLLM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code NRA·March 26, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 16, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008