12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LungQ v3.0.0
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Medos International Sàrl·10886705011247·ACORN REAMER, STERILE 20 - 130mm (Plus or Minus...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506074745·JUMBO MAYO STAND PART: FASTENING KNOB FOR UPPER...
INERTIA MIS PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
FDA 510(k)
FDA Class 1
·Ophthalmic
IMP TM 4.1MM MTX,13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 12, 2024
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 26, 2011
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 18, 2013
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 13, 2022
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026