23 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
FDA 510(k)
FDA Class 1
·Ophthalmic
artegral life
FDA UDI
Merz Dental GmbH·D7091993190·anteriors; shade B1; mould UBS
LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BD PureHub Disinfecting Cap
FDA 510(k)
FDA Class 2
·General Hospital
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 13, 2006
MAMMOTOME HARDWARE HOLSTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KNW·June 8, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 13, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 14, 2006
MAMMOTOME CONTROL MODULES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code KNW·June 13, 2006
Proteus XR/a (SlOK : K993090)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KPR·August 9, 2019
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 7, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2011
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
Proteus XR/a (SlOK : K993090)
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·October 2, 2019
BIOMET INTERLOK FIXED CRUCIATE TIBIAL PLATE 71MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018
VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 18MM X 71/75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018
BIOMET MODULAR TIBIAL LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018
VANGUARD FEMORAL DISTAL AUGMENT 5MM X 60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018