18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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