35 results · 22ms · Sources: EU EUDAMED, US FDA

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BONE-LOK HP WASHER

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (THC)

FDA UDI
Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690199656·Modular Knee Stem Pilot 25mm x 100mm

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981175474·Z-Rod, Dia. 5.5mm, Co-Cr, 250mm

Flosense II

FDA UDI
S D I DIAGNOSTICS INC·B279S298040250·FloSense II

TETRIC CERAM HB

FDA 510(k)
FDA Class 2 ·Dental

CAUTERY FORCEPS WITH FOOTSWITCH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·September 3, 2025

CADD

FDA Adverse Event
Malfunction ·ST PAUL·Product code FPA·April 21, 2021

STAINLESS STEEL BLADE

FDA Adverse Event
Malfunction ·STRYKER IRELAND LTD.·Product code LGH·November 7, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS LLC (PR)·Product code NIQ·April 8, 2013

CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·May 7, 2008

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·April 5, 2011

THREE PEG PATELLA 29MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 29, 2024

LOGIC KNEE SYSTEM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·February 7, 2023

LOGIC

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·May 30, 2024

LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·May 30, 2024

LOGIC

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 4, 2023

LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·November 1, 2023

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024