22 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Stowe Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780362227·McClure Iris Scissors 4-3/8", Angled on Flat, S...
Q-FLO CLOSED MALE LUER CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
TOKUYAMA TISSUECARE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
QUADRA-P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 15MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·October 17, 2014
PALMAZ GENESIS 29MM BILIARY
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code FGE·June 21, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011
VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024
SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
FDA Adverse Event
Injury
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 19, 2013
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025