16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LUNG AEROSOL UNIT
FDA 510(k)
FDA Class 2
·Anesthesiology
TLX
FDA UDI
Nuvasive, Inc.·00887517741028·TLX Tamp
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752176393·Arterial Blood Sampler
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000230·1.5 User All-In-One Vacuum w/ Integrated Air Wa...
Trimline
FDA UDI
ORMCO CORPORATION·00889989051278·UPPER LEFT FIRST MOLAR TRIMLINE BAND SIZE 23
Mini Standard Edgewise
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746113635·DB BKT MINI STANDARD EDGEWISE UNIV CUSP 022 T=0...
Rampart O
FDA UDI
SPINEOLOGY INC.·M7402800023·9x35mm Trial
MODIFICATION TO: SPIRIT
FDA 510(k)
FDA Class 2
·Anesthesiology
FRIENDLY LIGHT ER:YAG PULSED LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 8, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 17, 2012
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 12, 2010
LINER FOR METAL BACK GLENOID SMALL-R 2
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·November 23, 2020
SMR HUMERAL EXTENSION + 9 MM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·September 28, 2018
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025