55 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Tornier Latitude
FDA UDI
TORNIER, INC.·00846832014828·HUMERAL BROACH
SOAR Portal Retractor System
FDA UDI
SPINEOLOGY INC.·M7403030045·Dilator 22MM
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037309025·END ROD CANNULATED GLENOSPHERE IMPACTOR
Patriot Spinal Fixation System
FDA UDI
VALORUS SPINE LLC·00811771032998·Straight Rod, 45mm
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68111000300450·5.5mm x 45mm Contoured Rod
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023063·B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/U...
NA
FDA UDI
STRYKER CORPORATION·04546540756572·UNIVERSAL WEDGE 8MM X 30MM (1.5MM BORE)
uNion MAX
FDA UDI
Ulrich Medical Usa, Inc.·00810076334646·High Angulation Plate, 3-Level, 45 mm
SYNOVO HIP COMPONENTS
FDA UDI
Synovo Production·00814193025692·HIP FEMORAL RESURFACING CUP - 45.5 MM
Palladian™
FDA UDI
NEUROSTRUCTURES, INC·00841508102328·Curved Rod 45mm
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·INTRASTENT DOUBLESTRUT STENT
POSITUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
HA-TI (HAND TITANIUM SCREW) IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Biocore9 Femoral Resurfacing Component
FDA UDI
Biocore9, LLC·00810068850420·Biocore9 Femoral Resurfacing Head Component 45....
Ambassador
FDA UDI
Choice Spine, LP·10885862269201·
STONEBREAKER SINGLE USE PROBE
FDA Adverse Event
Malfunction
·COOK INC·Product code FFK·March 28, 2018
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
FDA Enforcement
Class II
·Ongoing·Synovo Production·April 17, 2024
BI-METRIC LAT PC 13X145MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWZ·November 9, 2016
BI-METRIC LAT PC 12X140MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·November 9, 2016