Camera, Television, Surgical, With Audio

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Shanghai.

Shanghai FLY Medical Devices Co., Ltd. Shanghai

How Is FWC Classified?

Camera, Television, Surgical, With Audio is FDA product code FWC, Class 1, 21 CFR 878.4160.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Camera, Television, Surgical, With Audio

Medical Facets NC

2.4mm Cannulated Screw, Self Drilling, Short Thread, 24mm

Camera, Television, Surgical, With Audio

Integra®

Integra® Fixed Focus Headlight Camera System Monitoring Bracket

Camera, Television, Surgical, With Audio

Integra®

Fixed Focus Headlight Camera System (NTSC) Camera Control Unit ONLY

Camera, Television, Surgical, With Audio

VoirElite 4k 31.5 Surgical Display

Surgical Display for Operating Room

Camera, Television, Surgical, With Audio

Otopront

4 catalogue numbers from PES Pilot HDpro, listed by Happersberger Otopront Gmbh, Germany, under Camera, Television, Surgical, With Audio. 1 manufacturer in China is registered for this product code.

Camera, Television, Surgical, With Audio

Which Manufacturers in China Make This?

How Is FWC Classified?

How Does It Reach the US Market?

Medical Facets NC

Integra®

Integra®

VoirElite 4k 31.5 Surgical Display

Otopront

Where China Actually Supplies