28 results
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20ms
·
Sources: EU EUDAMED, US FDA
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143741·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001374·artVeneer life upper anteriors, BIM, C3
CCF Film Anterior BLUE Bite Block 12 Pack
FDA UDI
CLIKTECH LLC·00856200001374·CCF Film Anterior BLUE Bite Block 12 Pack
3M™ Unitek™
FDA UDI
3m do Brasil Ltda.·00652221002198·Unitek(TM) Standard Edgewise Bracket Single Nar...
LIFEPAK® 15 monitor/defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00883873884126·15AABAABBBBBBABAAAAAAAABLP15 MONITOR/DEFIB
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COSMED QUARK
FDA 510(k)
FDA Class 2
·Anesthesiology
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·December 21, 2021
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·December 21, 2021
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·December 21, 2021
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·December 21, 2021
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
PICC NATE
FDA Adverse Event
Injury
·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007
LOCK-L-PL-2 LE 5HO TI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·March 13, 2013
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIO·February 25, 2011
TRUE TRACK SMART SYSTEM
FDA Adverse Event
Malfunction
·HOME DIAGNOSTICS, INC.·Product code NBW·February 20, 2008
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·August 1, 2022
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·May 10, 2024
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·July 26, 2022