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