18 results · 22ms · Sources: EU EUDAMED, US FDA

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RADIANCE ULTRA 32 4K ZEROWIRE DUO

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Pressure Sentinel® Intramedullary Reaming System

FDA UDI
Zimmer, Inc.·00889024039193·

MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

FDA 510(k)
FDA Class 2 ·Dental

INION CPS ORBITAL PLATES

FDA 510(k)
FDA Class 2 ·Dental

STATAK SUTURE ANCHOR WITH SUTURE

FDA Adverse Event
Malfunction ·ZIMMER INC·Product code MBI·August 10, 2011

RADIAL JAW 3 BIOPSY FORCEPS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCL·November 6, 2008

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013

ORTHOPEDIC SALVAGE SYSTEM BOWED IM STEM WITH SCREW 14.5MM X 225MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDI·January 3, 2019

ALINITY I HAVAB IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·November 26, 2025

ALINITY I HAVAB IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·July 22, 2025

ALINITY I HAVAB-IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

ALINITY I HAVAB-IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

ALINITY I HAVAB IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·January 23, 2026

ALINITY I HAVAB IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·January 16, 2026

BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025