12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
3M LASER IMAGER XL
FDA 510(k)
FDA Class 2
·Radiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756972949·EXTREMITY PACK
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
TAKE 1 ADVANCED RIGID TRAY
FDA 510(k)
FDA Class 2
·Dental
BD FACSARIA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·August 10, 2020
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 24, 2010
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
36MM COCR MOD HD +9MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 2, 2014
BD FACSCANTO¿ II FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·October 10, 2022
BD FACSCANTO¿ IVD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·December 27, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024