16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
LEONE SPA
FDA UDI
LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481120831·Attachment System, WP, Tissue Level, Blue Sky B...
Precision Xceed Pro
FDA UDI
ABBOTT DIABETES CARE INC·00357599000257·Precision Xceed Pro
10L4 Ultrasonic Transducer(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088792·
OPTIDOS
FDA 510(k)
FDA Class 2
·Radiology
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 3, 2021
F090705-1 GB DETACHABLE POWER CORD X1
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·December 29, 2020
F090705-1 GB DETACHABLE POWER CORD X1
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·December 29, 2020
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·December 29, 2015
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 2, 2013
FLOSTEADY - ARTHROSCOPY POLE PUMP
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY-SAN JOSE·Product code HRX·September 15, 2014
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
FDA Recall
Terminated
·Guidant Corporation·Product code NIK·June 17, 2005
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018