3,439 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXALT Model B Single-Use Bronchoscope
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Altus Spine Interbody Fusion System
FDA UDI
Altus Spine, LLC·00843210131634·Broach Trial
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020824·FPS 2.0mm x 14mm Locking Screw
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100142·EVOS Straight HA PEEK 14mm x 9mm x 22mm Biconve...
10M - General Purpose
FDA UDI
Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075145·FPS 2.0 x 14mm Locking Screw Sterile Qty 5
Medical Nitrile Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
FDA 510(k)
FDA Class 2
·Radiology
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION.·Product code LGW·November 6, 2008
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·August 17, 2011
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 5, 2013
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 1, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 5, 2014
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 1, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 5, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 15, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 2, 2014