12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
COACH 777-3
FDA 510(k)
FDA Class 2
·Physical Medicine
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 28, 2023
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 3, 2024
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 22, 2013
PRO ADVANTAGE BY NDC URINE PREGNANCY CASSETTE
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·April 14, 2011
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM·Product code FNL·July 3, 2008
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018