30 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
FDA 510(k)
FDA Class 2
·Cardiovascular
Implant Prosthetics
FDA UDI
Preat Corporation·00842092130339·NobelBiocare™ Tri-Lobe-compatible NP Engaging V...
Preat Implant Prosthetics
FDA UDI
Preat Corporation·00842092180730·NobelBiocare™ Tri-Lobe-compatible NP Engaging V...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092137949·NobelBiocare™ Tri-Lobe-compatible NP Engaging V...
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862161161·
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 28, 2025
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520004300·Curved Ti Rod, 430mm
PediFlex
FDA UDI
ORTHOPEDIATRICS CORP.·00841132119563·3.0mm Flex Nail Cap SS
TRIPLE LUMEN BREAST IMPLANT
FDA Adverse Event
Injury
·MCGHAN MEDICAL CORP.·Product code FTR·January 21, 1994
HARDYDISK, NALIDIXIC ACID, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TRIPLE LUMEN SILICONE BREAST IMPLANT
FDA Adverse Event
Injury
·MCGHAN MEDICAL CORP.·Product code FTR·January 21, 1994
TUFF TT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·September 8, 2024
ENDOSCOPIC CO2 REGULATION UNIT
FDA Adverse Event
Injury
·SHIRAKAWA OLYMPUS CO., LTD.·Product code HIF·October 3, 2024
APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 12, 2013
BLUE MAX 20 BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·February 24, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·February 21, 2008
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012