22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
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·05056139243837·UNITY KNEE™ PS-C INSERT - Size 6 x 12mm
Bard® Urethral Catheter
FDA UDI
C. R. Bard, Inc.·00801741029950·Bard® Tiemann Model Urethral Catheter Coude Tip
ZAVATION F3D-Z CIF
FDA UDI
Zavation LLC·00197157020507·F3D-Z CIF 14mmx16mmx12mm -6 deg
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113379·PS Insert, Size 6 x 12mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160350·
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481477788·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383505710·Gutta Percha Points is used to root canal filin...
SULTAN SPOROX TEST VIAL, MODEL 75195
FDA 510(k)
FDA Class 2
·General Hospital
VOCO IONOFIL MOLAR AC QUICK
FDA 510(k)
FDA Class 2
·Dental
K2M General Instruments
FDA UDI
VB Spine LLC·10888857551312·Offset Blade Left Size 60 mm
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 12, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 20, 2013
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·June 10, 2011
G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 13, 2008
OPEN SPINE CLAMP, TITANIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·August 5, 2014
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 Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·October 15, 2012