12 results · 19ms · Sources: EU EUDAMED, US FDA

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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