14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
BIODATA TESTOSTERONE MAIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128601·Revision Fluted Stem 10mm x 150mm
Zuma
FDA UDI
Seaspine Orthopedics Corporation·10889981096335·Zuma Inserter, Plate Engagement
MONARK 869 ERGOMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BARD(R) SYRINGE ASSIST IRRIGATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STOCKERT S3 LEVEL SENSOR MOUNTING PADS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTW·August 2, 2012
SENSOR MODULE LEVEL/BUBBLE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTW·May 11, 2012
CBCII BLOOD CONSERVATION KIT W/1/4 INCH ROUND PVC WOUND DRAIN
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS-KALAMAZOO·Product code CAC·February 11, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
CYBERINFE ROBOTIC RADIOSURGERY SYSTEM
FDA Adverse Event
Injury
·ACCURAY, INCORPORATED·Product code IYE·July 7, 2014
STOCKERT S3 LEVEL SENSOR MOUNTING PADS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·January 6, 2012
S5 BUBBLE DETECTOR SENSOR 3/16''
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·February 25, 2022
STOCKERT S3 LEVEL SENSOR MOUNTING PADS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTW·January 6, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021