12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLV CONTINUUM VENTILATOR, MODEL P2000
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034032·Baltic Denture System BDLoad BDLoad Sm7 PLSEbm...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120340321·Diamond, round, coarse grit, green ring
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410340320·Anterior Closing Osteotomy Guide, 34mm x 32mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420340320·Anterio Lateral Wedge Osteotomy Guide, 34mm x 32mm
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PERFECTA AND EXTEND
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 10, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 3, 2013
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 30, 2011
3.5MM 90-S SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·April 24, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012