30 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIODENTINE
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125120·20-30 MV FOR MEN CLSC CALF STD TAN II
Accent Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989053760·ACCENT B/T 5SGL F/S NDX -27TX18 LR
Fuji Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711401321·32mm Level 1 Cervical Plate System - Fuji
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981208806·Trial, 11mm x 40mm x 13mm, 20 deg
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036032012·
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981201685·Interbody, 11mm x 40mm x 13mm, 20 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981193690·Interbody, 11mm x 40mm x 13mm, 20 deg
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132611·IN-OVATION® C Roncone 022 U3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132101·IN-OVATION® C Base Rx 022 U3-3 CS HK
MUSE CARDIOLOGY INFORMATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 27, 2002
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CGA·May 3, 2000
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·August 8, 2007
BALANCED KNEE SYSTEM
FDA Adverse Event
Malfunction
·ORTHO DEVELOPMENT CORP.·Product code JWH·May 29, 2013
IDENTITTY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011