28 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Road, Shanghai 201114, P.R. Chin., Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Covidien Medical Products (Shanghai) Manufacturing LLC, Building No. 10, 789 Puxing Rd., Shanghai 201114, P.R. China. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles.
FDA Recall
Terminated
·Covidien, PLC·Product code GEI·November 4, 2011
GE Carestation 30 anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE 9100c NXT anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Recall
Terminated
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018
Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code ITX·March 21, 2009
GE Carestation 30 anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
FDA Enforcement
Class II
·Terminated·Covidien LP·June 12, 2013
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
FDA Enforcement
Class II
·Terminated·Covidien LP·June 12, 2013
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
FDA Enforcement
Class II
·Terminated·Covidien LP·June 12, 2013
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
FDA Enforcement
Class II
·Terminated·Covidien LP·June 12, 2013
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
FDA Enforcement
Class II
·Terminated·Covidien LP·June 12, 2013
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
FDA Enforcement
Class II
·Terminated·Covidien LP·June 12, 2013
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·September 5, 2012
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
GE 9100c NXT anesthesia systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems China Co., Ltd.·September 5, 2018
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
FDA Recall
Terminated
·Argo Medical Technologies Ltd Matambuilding 30p.O.Box·Product code PHL·February 28, 2020
Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
FDA Recall
Terminated
·Trumpf Medical Systems, Inc.·Product code JEA·December 3, 2014