14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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