10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PATIENT HEATER SYSTEM, MODEL PH112
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517821881·Interlock II Trial, 15x17x14mm 10° Stop
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
NOSECLIP FOR RESP. CARE & PULMON. FUNC.
FDA 510(k)
FDA Class 1
·Anesthesiology
UNKNOWN COOL TIP ELECRTRODE
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·March 3, 2020
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·September 25, 2025
UNKNOWN KNEE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 25, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 2, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 18, 2007
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021