10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXPD 4343D; EXPD 3643D
FDA 510(k)
FDA Class 2
·Radiology
HQ-Chex
FDA UDI
STRECK, INC.·20844509001670·A whole blood glucose and hemoglobin control de...
MICROAIRE MIDFACE ST
FDA Adverse Event
Malfunction
·MICROAIRE SURGICAL INSTRUMENTS·Product code GAM·February 17, 2016
iHealth Wireless No-Touch Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
GLUCOSE TOLERANCE BEVERAGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·March 8, 2007
VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARIDAC SURGERY·Product code GEI·November 14, 2008
ALTRX NEUT 32IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 18, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025