9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
FDA 510(k)
FDA Class 2
·Ophthalmic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776207281·Small Joint Probe
POWERGLIDE MIDLINE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
TI CERVICAL SPINE LOCKING PLATE VARIABLE ANGLE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·November 13, 2008
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 4, 2011
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025