11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NERIA MULTI SUBCUTANEOUS INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 39cm x 125°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665023343·
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017695·Hook Punch 15 degree up milled 3.5mm 45 degree ...
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HARMONY VLED SURGICAL LIGHTNING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 24, 2012
GENESYS HTA PROCERVA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·May 20, 2013
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
PRODISC-C IMPLANT MEDIUM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MJO·June 3, 2011
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015