23 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Eckert & Ziegler Isotope Products, Inc.
FDA UDI
Eckert & Ziegler Isotope Products, Inc.·00810117211257·Attenuation Correction Line Source
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530191·
KineMatch® PFR System
FDA UDI
Kinamed, Inc.·00818720011042·PATELLA RESECTION GUIDE
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523164271·Bayonet Left Angle Curette Size 4
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172207·SA ALIF 2 Hole Speed Guide, 19mm
EBI XFIX DFS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SINGLE SIZE TENDON SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
UNICEL® DXC 600 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·March 13, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 28, 2011
INVACARE SHOWER / BATH SUPPORT PRODUCTS
FDA Adverse Event
Injury
·INVACARE CORP. - MANUFACTURING FACILITY·Product code INM·February 25, 2008
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·April 7, 2022
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·April 5, 2022
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·March 29, 2022
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·March 29, 2022
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·March 29, 2022
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·March 29, 2022
EXACTECH
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code LXH·March 29, 2022
2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·November 10, 2014
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026