55 results · 23ms · Sources: EU EUDAMED, US FDA

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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