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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIA Elas Baltic
FDA registration
SIA Elas Baltic·3 products·🇱🇻 Latvia
ELAS-O-LOOP
FDA UDI
Ortho Arch Company Inc·D90927020917·ELAS-O-LOOP DB HOOK (10)
Lilly Pulitzer
FDA UDI
Kenmark Optical, Inc.·00715317057080·Ella Aqua Spectacle
Lilly Pulitzer
FDA UDI
Kenmark Optical, Inc.·00715317057073·Ella Aqua Spectacle
Lilly Pulitzer
FDA UDI
Kenmark Optical, Inc.·00715317057103·Ella Tortoise Spectacle
Lilly Pulitzer
FDA UDI
Kenmark Optical, Inc.·00715317057097·Ella Tortoise Spectacle
Lilly Pulitzer
FDA UDI
Kenmark Optical, Inc.·00715317079204·Ella Purple Spectacle
Lilly Pulitzer
FDA UDI
Kenmark Optical, Inc.·00715317079198·Ella Purple Spectacle
BREATHABLE OVERWRAY BANDAGE NON-ELAS
FDA 510(k)
FDA Class 1
·General Hospital
ELA MEDICAL ANATEC HOLTER SCANNER
FDA 510(k)ELA MEDICAL UNILITH PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
Phoenix Elastic Attachers
FDA UDI
PHOENIX ORTHODONTICS INC·05060772890006·ELASTIC ATTACHERS MIXED COLORS PK100
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
ELA MEDICAL PACING LEAD MODEL PMA 860
FDA 510(k)ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
FDA 510(k)
FDA Class 3
·Cardiovascular
Orantech
FDA UDI
Orantech Inc.·06941691966432·GE Marquette Compatible, Philips adapter, 5-Lead
Orantech
FDA UDI
Orantech Inc.·06941691966449·GE Marquette Compatible, Spacelabs adapter, 5-Lead
Orantech
FDA UDI
Orantech Inc.·06941691960577·GE Marquette Compatible,COVIDIEN adapter, 5-Lead
Orantech
FDA UDI
Orantech Inc.·06941691966487·Spacelabs Compatible, Siemens adapter, 5-Lead
Orantech
FDA UDI
Orantech Inc.·06941691966494·Spacelabs Compatible,Nihon Kohden adapter, 5-Lead