14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Surgical Planning Software version 1.1
FDA 510(k)
FDA Class 2
·Radiology
B-P TOTAL HIP SYSTEM
FDA UDI
ENDOTEC, INC.·00814193023575·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 21, 2023
VASCUCOMP
FDA 510(k)
FDA Class 2
·Cardiovascular
US/SS/GS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
1823260-2017-01519
FDA Adverse Event
Malfunction
·July 24, 2017
BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·September 6, 2024
GMK-HINGE FEMORAL COMPONENT SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·July 25, 2022
HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FMJ·June 6, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 25, 2021
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 19, 2019
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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