8 results · 6ms · Sources: EU EUDAMED, US FDA

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Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

FDA classification
FDA Class 2 ·Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

ATW MARKER WIRE STEERABLE GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

FDA 510(k)
FDA Class 2 ·General Hospital

Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

FDA classification
FDA Class 2 ·Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA classification
FDA Class 2 ·Calibrator, Hearing Aid / Earphone And Analysis Systems

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)

FDA 510(k)
FDA Class 2 ·Cardiovascular

Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)

FDA 510(k)
FDA Class 2 ·Cardiovascular