13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVIA Centaur® Anti-Müllerian Hormone (AMH)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD BBL™ Mueller Hinton Agar with 5% Sheep Blood
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902218019·BD BBL™ Mueller Hinton Agar with 5% Sheep Blood...
Portex
FDA UDI
ICU MEDICAL, INC.·15019517085846·
IQ FLEX M
FDA Adverse Event
Malfunction
·FIRST SOURCE INC.·Product code IZL·May 29, 2024
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
QUINTEX CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXTEND IS-1 BI POSITIVE FIX
FDA Adverse Event
Death
·CARDIAC PACEMAKERS, INC·Product code DTB·November 9, 2004
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·November 3, 2014
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·August 24, 2011
DUROM HIP GENERIC
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·July 9, 2013
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023