14 results · 21ms · Sources: EU EUDAMED, US FDA

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HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

FDA 510(k)
FDA Class 2 ·Hematology

Costco

FDA UDI
Bernafon AG·05711584089927·CAPTO 1 MNR, 2.4G NFM PB MSIL COSTC

Edge™ Diamond FP018-4.0F Football Pointed

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003384·Diamond dental bur, reusable

ADHESIVE ELECTRODES

FDA 510(k)
FDA Class 2 ·Neurology

ECHOPLAQUE

FDA 510(k)
FDA Class 2 ·Radiology

WALLSTENT RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

WALLSTENT ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 22, 2025

WALLSTENT ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025

AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-PUERTO RICO·Product code JDZ·October 22, 2014

UNKNOWN EXTERNAL NEUROSTIMULATOR

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·June 27, 2013

WALL STENT ENDOPROSTHESIS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code FGE·January 25, 2007

WALLSTENT? RP ENDOPROSTHESIS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021