16 results · 16ms · Sources: EU EUDAMED, US FDA

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General Cutting Straight

FDA 510(k)
FDA Class 1 ·Dental

General Cutting Contra Handpiece

FDA 510(k)
FDA Class 1 ·Dental

General Cutting Contra Handpiece

FDA 510(k)
FDA Class 1 ·Dental

KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

FDA Enforcement
Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024

SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

FDA Enforcement
Class II ·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016

SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

FDA Enforcement
Class II ·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016