18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FIBERGRAFT BG Putty Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121968·LOCATOR F-Tx Abutment For 4.05mm Platform Exter...
Denovo Preformed Matrix Band
FDA UDI
Denovo Dental, Inc.·00810059290860·Denovo Preformed Matrix Band - Pediatric 3/16, ...
PAINT- ON POLISH AGENT
FDA 510(k)
FDA Class 2
·Dental
KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 14, 2013
ONCOR IMPRESSION PLUS
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS·Product code IYE·September 12, 2008
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025