9 results
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80ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·August 31, 2016
The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·October 15, 2014
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·July 17, 2019
The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·March 23, 2016
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·November 13, 2013
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·March 11, 2015
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·February 17, 2016
Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·February 17, 2016
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
FDA Enforcement
Class II
·Terminated·Richard Wolf Medical Instruments Corp.·February 17, 2016