19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
FDA 510(k)
FDA Class 2
·Ophthalmic
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176163394·Bone cutter Allport HP 1,0 mm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306815492·Ribbon Retractor, Malleable, Width: 25 mm, Leng...
Duo Ti Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7403110129·Graft Pusher
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776021511·Pin Mat
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
FDA 510(k)
FDA Class 2
·Radiology
BD PLASTIPAK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 14, 2022
OSTEOSELECT DBM PUTTY
FDA Adverse Event
Injury
·BACTERIN·Product code MQV·November 29, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 13, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·September 23, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 19, 2011
BD PHOENIX¿ AP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JQX·August 2, 2021
BD SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 8, 2022
Port Tray Catalog 7607
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·January 24, 2024
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025