Accessories, Photographic, for Endoscope (Exclude Light Sources)

Which Manufacturers in China Make This?

8 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Anhui and Beijing, and 3 other provinces. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Anhui Shiyin Photoelectric Instrument Co., Ltd. Anhui
Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd Beijing, contract manufacturer
Hunan Vathin Medical Instrument Co., Ltd. Hunan
Jiangsu Mole Electronic Technology Co., Ltd. Jiangsu, contract manufacturer
Qingdao O-MEC Medical Technology Co., Ltd. Shandong, contract manufacturer
Shenzhen Besdata Technology Co., Ltd. Guangdong
Shenzhen Hugemed Medical Technical Development Co., Ltd. Guangdong
Zhongshan Wesee Meditech Co., Ltd. Guangdong, contract manufacturer

How Is FEM Classified?

Accessories, Photographic, For Endoscope (Exclude Light Sources) is FDA product code FEM, Class 1, 21 CFR 876.1500.

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.

What Has Gone Wrong With It?

The FDA has recorded 5 recalls under this product code since 2003. 1 was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Equipment maintenance (1) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Pylon

Catalogue number ST-A1, listed by Hunan Vathin Medical Instrument Co., Ltd., China, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Imaging

ZOOM Coupler, F=16-34MM

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Lumax™ TS Pro

Lumax™ TS Pro Fiberoptic Cystometry System Sales Demo Unit

Accessories, Photographic, For Endoscope (Exclude Light Sources)

TV-adapter

TV-adapter: short design, f = 15.0mm HD+4K, c-mount, soakable

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Scope Pole

Catalogue number MAJ-1777, listed by Olympus Medical Systems Corp., Japan, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Compact Trolley

Catalogue number TC-A1, listed by Olympus Medical Systems Corp., Japan, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED 35MM Optical Coupler

Catalogue number CPL 35, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Universal Filter

Catalogue number 220-25, listed by SBI Pharmaceuticals Co., Ltd., under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Trolley

Catalogue number MET-A1, listed by Hunan Vathin Medical Instrument Co., Ltd., China, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Energy Cart

"TC-E400 Energy Cart"

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Light Cable, ACMI-Olympus, 1mm

Catalogue number 5160-100, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Adapter, Storz

Catalogue number 5196-903, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

ARM Clamp 1

"MAJ-684 Arm clamp for MAJ-683&TC-E1/TC-2"

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED 25MM Optical Coupler

Catalogue number CPL 25, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Adapter, Wolf/Dyonics

Catalogue number 5196-904, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

CO2BOTTLE Holder

Catalogue number MAJ-1773, listed by Olympus Medical Systems Corp., Japan, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED 22MM Optical Coupler

Catalogue number CPL 22, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Conmed

Replacement Scope Fiber Post Adapters Wolf/Storz

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Light Cable, ACMI-Storz, 1mm

Catalogue number 5154-100, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Ambu Aview™ 2 Advance

Ambu aView 2 Advance

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Arthrex®

Coupler, 90 Degree, C-MT

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED 20MM Optical Coupler

Catalogue number CPL 20, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Video Camera Insert/Filter

Video Camera Insert/Filter - For Rigid Endoscopes

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Universal Light Cable

Catalogue number 5196-100, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Guard Rail

Catalogue number MAJ-1772, listed by Olympus Medical Systems Corp., Japan, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED Endopro-CAM® Elite Camera Stand

An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy…

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Accessories, Photographic, for Endoscope (Exclude Light Sources)

5197-801 Zoom Coupler, 17.5MM

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Supporting ARM

"MAJ-683 Probe driver arm"

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Fusion

FIBER LIGHT CABLE Ø 5MM TL 2.3M temperature stable, color code gray

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Endocraft LLC

Fiber optic light carrier for surgical illumination through endoscope. Connects to Light cable.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED Power Bank Battery, Rechargeable

Catalogue number K100, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Adapter, Acmi

Catalogue number 5196-901, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Video Camera Insert

Video Camera Insert/Filter For Rigid Endoscope

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Adapter, Olympus

Catalogue number 5196-902, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED 28MM Optical Coupler

Catalogue number CPL 28, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

ARM Clamp 2

"MAJ-851 WM-30/60 & MAJ-683 arm clamp"

Accessories, Photographic, For Endoscope (Exclude Light Sources)

AED 18-35MM Zoom Optical Coupler

Catalogue number CPLZ 1835, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Connecter Holder Rubber

Catalogue number MAJ-1779, listed by Olympus Medical Systems Corp., Japan, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Accessories, Photographic, for Endoscope (Exclude Light Sources)

Coupler, Optical Zoom, Autoclavable 14 - 29 mm Focal Range

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Fujifilm

This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

ScopEYE

4 catalogue numbers from SE-EDN, listed by MediThinQ Co., Ltd., South Korea, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Base Unit

Catalogue number MAJ-1776, listed by Olympus Medical Systems Corp., Japan, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Riwomobil

UNIT CART PREMIUM-ELEC. 100-120VAC Universal device cart with reinforced bridge for mounting swivel arms, incl. rear panel and integrated cable duct. 3 shelf units (width 370 mm), 2 of…

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Zeos

Zeos Zoom Coupler, F=16-34MM

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Olumpus

Catalogue number TC-C4, listed by Keymed (Medical & Industrial Equipment) Ltd, United Kingdom, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Video Camera Insert

Video Camera Insert - For Rigid Endoscopes

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Gimmi

Adapter FOR Endoscope FOR Gimmi / Storz Light-Cable With Thread

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Light Cable, ACMI-Wolf/Dyonics, 1mm

Catalogue number 5161-100, listed by Clarus Medical, LLC., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Lumax™

Lumax™ Software Update pack

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Pentax

Adapter for P.Fiberscope to PVA-1010 AP-PV1

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Riwo

ANGLED LENS F 17MM for camera heads with 1/3 inch image sensors, 5:4 and 4:3, C-Mount with rotatable Snap-On lock

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Sales Demo Software

Catalogue number 23485-SRD, listed by Coopersurgical, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Trolley With Pylon

Catalogue number MET-A2, listed by Hunan Vathin Medical Instrument Co., Ltd., China, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Fusion Design

ADAPTER ENDOSCOPE SIDE for connecting a WOLF light cable to WOLF telescopes, quick connect with ring connector, short version, reusable

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Olympus

39 catalogue numbers from WM-NP3 Mobile Workstation ROW, listed by Keymed (Medical & Industrial Equipment) Ltd, United Kingdom, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Light Cable, Acmi-Acmi, 1mm

Accessories, Photographic, For Endoscope (Exclude Light Sources)

Accessories, Photographic, for Endoscope (Exclude Light Sources)

FLEXION-PORT 350+300 (93CM) Support arm (two pieces) with effective length of 93cm (measured between rotating axis). VESA 100. Integrated cable channel, mechanical transport locking. Load:…

Accessories, Photographic, for Endoscope (Exclude Light Sources)

Which Manufacturers in China Make This?

How Is FEM Classified?

How Does It Reach the US Market?

What Has Gone Wrong With It?

Where China Actually Supplies