595 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIMPLANT Online Case Review and SIMPLANT Editor
FDA 510(k)
FDA Class 2
·Radiology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515023260·Forester Sponge Fcp, str, 14"
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916141875·ZEUS®-L Cobb Elevator Angled Tip 16mm
Symmetry Rochester-Pean
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482040294·Symmetry® Forceps, Rochester-Pean Hemostatic, C...
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020751·Cruciate Retaining Tibial Insert
THREADED STEINMANN PINS, TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016387·
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVON TULLE
FDA 510(k)
FDA Unclassified
·Unknown
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 17, 2011
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 1, 2010
OT ULTRA EASY METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 3, 2012
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 7, 2010
OT ULTRA EASY METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 14, 2012
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 3, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 2, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 11, 2011