13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SPETZLER PIN
FDA 510(k)
FDA Class 2
·Orthopedic
Stainless Steel Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746115226·COSMETIC BRACKET LINGUAL MAX CENT 018 55 TQ PRO...
Harken Auricle Clamp
FDA UDI
KOROS U.S.A., INC.·10840199540188·Harken Auricle Clamp #1 Curve 24cm 9-1/2"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041126·Tag, 0 Degree ExtremiFuse, 2.4
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041119·Tag, 0 Degree ExtremiFuse, Blank
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041133·Tag, 0 Degree ExtremiFuse, 3.0
CERTI-FORM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
FDA 510(k)
FDA Class 2
·Radiology
SYNCARDIA COMPANION DRIVER CADDY
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, INC.·Product code LOZ·January 15, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 16, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2014
10.0MM REAMER HEAD FOR RIA 2 STERILE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTO·December 2, 2021
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023