8 results · 24ms · Sources: EU EUDAMED, US FDA

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MANIPULATOR; MANIPULATOR PRO

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)

FDA 510(k)
FDA Unclassified ·Unknown

HEMOSIL PROTEIN S ACTIVITY ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

BATHLIFT BLISS RECLINER US AB

FDA Adverse Event
Malfunction ·HANDICARE·Product code FSA·May 23, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 5, 2014

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 28, 2011

BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 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