8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ADJUSTABLE FORK RETRACTOR
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
FDA 510(k)
FDA Class 2
·Neurology
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 29, 2012
JUVERDERM (VOLUME/CONCENTRATION UNKNOWN)
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·June 8, 2015
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018