11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
FDA 510(k)
FDA Class 2
·Orthopedic
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·April 25, 2014
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code NPJ·April 25, 2014
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 17, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 3, 2011
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
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025