246 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ELECTRO SENSOR -BODY COMPOSITION
FDA 510(k)
FDA Class 2
·Cardiovascular
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
FDA 510(k)
FDA Class 2
·General Hospital
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
FDA 510(k)
FDA Class 2
·Ophthalmic
BAHO AUTOCLAVABLE LAPAROSCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
FDA 510(k)
FDA Class 2
·Orthopedic
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·FLEXTOME CUTTING BALLOON MONORAIL
COOLAN 300
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Human Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PSA ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
VENTANA CEA PRIMARY ANTIBODY
FDA 510(k)
FDA Class 2
·Immunology
PAP ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
Bone Sonometer
FDA Pre-Market Approval
FDA Class 2
·ACHILLES INSIGHT ULTRASONOMETER
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
FDA 510(k)
FDA Class 2
·General Hospital
Monitor, Carbon-Dioxide, Cutaneous
FDA Pre-Market Approval
FDA Class 2
·LITTON TRANSCUTANEOUS CO2 SYSTEM
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·NORIAN SRS CEMENT
Monitor, Carbon-Dioxide, Cutaneous
FDA Pre-Market Approval
FDA Class 2
·RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·BONECEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLEX(R) P BONE CEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·SURGICAL SIMPLEX BONE CEMENT