13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Phonak
FDA UDI
Phonak AG·07612847978447·Naída S CRT V (palladium/black)
XIA STAINLESS STEEL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·April 23, 2013
GALILEO ECHO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 29, 2011
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008
MAGNUM TRISPIKE CUP 58ODX52ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 4, 2018
M2A-MAGNUM MOD HD SZ 52MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 4, 2018
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Recall
Terminated
·Zest Anchors LLC·Product code DZE·January 16, 2014
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878
FDA Enforcement
Class II
·Terminated·Zest Anchors LLC·February 12, 2014
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019