12 results
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17ms
·
Sources: EU EUDAMED, US FDA
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909129352·REVELATION DIAMOND 856-018M - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110874·TIP GUARDS VENTED GREEN PACK OF 100
SYNCHRON CREATINE KINASE REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code CGS·June 17, 2011
CAPERE Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
THECURVE, ITEM 507
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORCE FX
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·November 18, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 3, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 30, 2012
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025
GENESIS UNI KNEE FEMORAL COMPONENT COCR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024