17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Portable Mesh Nebulizer
FDA 510(k)
FDA Class 2
·Anesthesiology
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025
UNITY BETA ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 11, 2019
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 17, 2014
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021
ACDF STAND ALONE CERVICAL
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016