14 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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A4722 OLYMPUS OPTICAL OBTURATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Acetabular reamer ø55mm
FDA UDI
Incipio Devices SA·07630055302816·Acetabular reamer for hip arthroplasty
Clinical review 2MP
FDA UDI
Barco NV·05415334000452·MDRC-2324 SNIB
HarmonyAIR
FDA UDI
STERIS CORPORATION·00724995164959·The HarmonyAIR Utility Hub All Power Data 31.5-...
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693101134·Dehydrant Alcohol product lines are specificall...
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707052201·.018 SAA L7R -12T MINI TUBE
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
OneStep Pediatric CPR Multi-Function Electrode
FDA 510(k)
FDA Class 3
·Cardiovascular
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 27, 2014
TRILOGY SHELL WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER·Product code LPH·February 6, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·December 7, 2010
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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