18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
FDA 510(k)
FDA Class 2
·Cardiovascular
KING SEPTEMS
FDA Adverse Event
Malfunction
·KING SEPTEMS·Product code LMA·November 1, 2012
Unity Total Knee System
FDA UDI
CORIN LTD·05056139243875·UNITY KNEE™ PS-C INSERT - Size 6 x 16mm
Bard® Urethral Catheter
FDA UDI
C. R. Bard, Inc.·00801741029974·Bard® Tiemann Model Urethral Catheter Coude Tip
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113393·PS Insert, Size 6 x 16mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160350·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383556521·Gutta Percha Points is used to root canal filin...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857551350·Offset Blade Left Size 100 mm
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973100997·Poly Insert UCCS, Size 6, 16mm
BAYER RAPIDPOINT 405 SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·May 20, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·September 26, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 10, 2011
TREVO XP PROVUE 4MM X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012