11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JKH Stimulator Plus
FDA 510(k)
FDA Class 2
·Neurology
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
MultiPulse HoPLUS
FDA UDI
Asclepion Laser Technologies GmbH·04058784000996·Holmium Laser for Surgery
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191151811·IN-OVATION® mini EURO 018/UR5 -7T 0A HK
POWDER FREE NITRILE EXAMINATION GLOVE, GREEN TEA SCENTED, GREEN
FDA 510(k)
FDA Class 1
·General Hospital
REGENT ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ABBOTT NUTRITION·Product code LZH·July 25, 2011
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 26, 2008
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016