24 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOMOS MOTORIZED CRANE II
FDA 510(k)
FDA Class 2
·Radiology
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482050781·Symmetry® Knife Handle, Hexagonal, 6 in, 152 mm
UNBRANDED
FDA UDI
ADVANCE MEDICAL DESIGNS, INC.·00848340000201·Snap Kover
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130300·Wrench, Derotation, Double Ended
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588956·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588963·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588970·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588949·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588987·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588994·
ADVANTAGE WINDOWS CT/PET FUSION
FDA 510(k)
FDA Class 2
·Radiology
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
FDA 510(k)
FDA Class 1
·Ophthalmic
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107133·KNIFE HANDLE HEXAGONAL, 6"
SCHILLER
FDA Adverse Event
Malfunction
·SCHILLER AG·Product code MHX·November 2, 2006
BD EMERALD¿ SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·September 25, 2018
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2013
ASR 300 SPIKED CUP SIZE 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
PINN SECTOR W/GRIPTION 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·August 15, 2014
LAPRA-TY ABSORBABLE X6::SUTURE CLIP
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code FZP·December 22, 2022
9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010