19 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ULTRACHEM GLUC-DH SET, ITEM #65048
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ultraverse® 018
FDA UDI
Bard Peripheral Vascular, Inc.·00801741054945·Ultraverse® 018 PTA Balloon Dilatation Catheter...
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130421·Screw - Ø1.9 mm x 10 mm [5 PK]
Bioplate®
FDA UDI
Bioplate, Inc.·M384813042US1·Screw - Ø1.9 mm x 10 mm [5 PK]
REVOIS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DISCOVERY ELBOW
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN KUDO ELBOW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·May 17, 2017
DISC LT DSTL HMRL BDY SET
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·April 1, 2019
UNKNOWN KUDO ELBOW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·May 17, 2017
UNKNOWN KUDO ELBOW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·May 19, 2017
UNKNOWN KUDO ELBOW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·May 19, 2017
UNKNOWN KUDO ELBOW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·May 17, 2017
UNKNOWN KUDO ELBOW
FDA Adverse Event
Death
·BIOMET UK LTD.·Product code JDC·May 19, 2017
UNKNOWN KUDO ELBOW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·May 19, 2017
GUT CHROMIC SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAL·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
REPAIR CORE SUMEX DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·August 12, 2010
UNKNOWN KUDO ELBOW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDC·May 17, 2017
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015