19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Laser Treatment System, Model: NYX and Grace
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III
AMPLITUDE
FDA UDI
AMPLITUDE SAS·03701089500821·Resurfacing Patellar Implant NM Cemented Ø 33 mm
24PW - Safety General Purpose
FDA UDI
Certified Safety Manufacturing, Inc.·00766588100333·24PW - Safety General Purpose
Navagio
FDA UDI
Kalitec Direct LLC·B073DRK0100330·Assembly, Navagio Fixed Draw Rod, Large Knob
FEEL-DRCS
FDA 510(k)
FDA Class 2
·Radiology
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
SPACEMAKER STRUCTURAL BALLOON TROCAR
FDA Adverse Event
Malfunction
·PONCE-USS·Product code GCJ·October 21, 2008
MP30 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS.·Product code MHX·August 2, 2011
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 7, 2023
V.A.C. FREEDOM THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024