121 results
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78ms
·
Sources: EU EUDAMED, US FDA
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
FDA 510(k)
FDA Class 2
·General Hospital
INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601
FDA 510(k)
FDA Class 2
·Physical Medicine
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
FDA 510(k)
FDA Class 1
·Clinical Chemistry
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104
FDA 510(k)
FDA Class 2
·Anesthesiology
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·PROGEL PLEURAL AIR LEAK SEALANT WITH RECOMBINANT HUMAN ALBUMIN
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032
FDA 510(k)
FDA Class 2
·Radiology
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306
FDA 510(k)
FDA Class 2
·Orthopedic
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
FDA 510(k)
FDA Class 2
·General Hospital
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·3F AORTIC BIOPROSTHESIS
Aution™ AU Control Solution
FDA UDI
ARKRAY USA, INC.·04987486738060·Aution AU Control Solution is supplied in 2 dif...
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·SYNCHROMED II IMPLANTABLE INFUSION SYSTEM
AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
FDA 510(k)
FDA Class 2
·Orthopedic
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
FDA 510(k)
FDA Class 2
·General Hospital
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K)