18 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741124550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674112455060·
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605268·SPACER 2112455 OLIF25 20MM 12 DEG 14X55
Mayo Stille Scissors
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896120464·Mayo Stille Scissors Round Blades Tungsten Carb...
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VERSAFITCUP CC TRIO ACETABULAR SHELL 58 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·June 27, 2013
VERSAFITCUP CC TRIO CUP 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·December 14, 2012
M2A-MAGNUM RECAP CUP 46ODX40ID
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·December 13, 2018
M2A-MAGNUM MOD HD SZ 40MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·December 13, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
3 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 28, 2011
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021