14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526791145·MEDI CAT WALKER SHORT BOOT, LARGE
BASE
FDA UDI
Nuvasive, Inc.·00887517700346·BASE Guide, Single N
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094270·Tap Guide
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707052232·.022 EDGE U7L MINI HK BRKT
C/PES 9201, ECG STRESS TESTING SYS
FDA 510(k)
FDA Class 2
·Cardiovascular
SUPERCATH Z3V
FDA 510(k)
FDA Class 2
·General Hospital
IODINE (I-125) SEEDS
FDA Adverse Event
Injury
·GE HEALTHCARE·Product code KXK·February 6, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·December 7, 2010
ECHELON LINEAR CUTTER RELOAD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 22, 2014
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014