12 results
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19ms
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Sources: EU EUDAMED, US FDA
STASIS BUTTON PRSSURE DEVICE
FDA 510(k)
FDA Class 1
·General Hospital
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909127652·REVELATION DIAMOND 855-016SC - 5 PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110904·TIP GUARDS VENTED ORANGE PACK OF 100
DATASCRIBE #DS-40
FDA 510(k)
FDA Class 1
·Anesthesiology
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA 510(k)
FDA Class 2
·Dental
FOUNDATION HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWL·November 2, 2010
UNKNOWN SMALL DIAMETER FEMORAL HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·January 7, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 3, 2014
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 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021