87 results
·
22ms
·
Sources: EU EUDAMED, US FDA
DOSIMETRY CHECK
FDA 510(k)
FDA Class 2
·Radiology
Axcent Acrylics
FDA UDI
GARRECO, LLC·D79330102250·Repair Lt Fiber 25lb
Cholesterol LiquiColor®
FDA UDI
STANBIO LABORATORY, L.P.·00657498000656·For the Quantitative-Enzymatic-Colorimetric Det...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR50102251·Tweezer for positioning 2D-Lingual 5 mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100250·Caddie Lid, Fixed Cross Links 5.5mm
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 21, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 26, 2025
INSET I
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 5, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 27, 2025
HUDSON QUICK-COUPL REAMING SPEED F/TRS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 19, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·February 11, 2011
INTERSTIM TINED LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LGW·February 10, 2008
LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 27, 2024
LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 27, 2025
THREE PEG PATELLA 35MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 26, 2024
LOGIC RBK INSERT SZ 2.5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 31, 2024
LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 28, 2025
LOGIC KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 3, 2026