18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Accu-Joint Hemi Implant
FDA 510(k)
FDA Class 2
·Orthopedic
CORTRAK 2EAS
FDA UDI
CORPAK MEDSYSTEMS, INC.·10815149024599·CORTRAK 2 Enteral Access System Accessory Kit
CORTRAK* 2 Enteral Access System
FDA UDI
Avanos Medical, Inc.·00350770456485·Accessory Kit
Kinetic-SL Dynamic Anterior Cervical Plate System
FDA UDI
Life Spine, Inc.·00190837037161·12mm Fixed Screw, SL-FT-SD
CORTRAK 2EAS
FDA UDI
Avanos Medical, Inc.·10680651456486·HALYARD CORTRAK 2 Enteral Access System Accesso...
LUXAFORM
FDA 510(k)
FDA Class 2
·Dental
H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COCR HEAD 28/+4 'L' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code MEH·January 26, 2026
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 20, 2008
PROMUS ELEMENT ¿ LONG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 11, 2011
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
TALENT TAA
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 10, 2013
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 14, 2010
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 9, 2021
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016