9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
FDA Enforcement
Class II
·Terminated·Conformis Inc·August 29, 2012
Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
FDA Recall
Terminated
·Conformis Inc·Product code JWH·July 17, 2012
CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
FDA Recall
Terminated
·Metrex Research, LLC.·Product code LRJ·January 20, 2017
CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
FDA Enforcement
Class II
·Terminated·Metrex Research, LLC.·March 15, 2017
Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes.
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code KBJ·January 29, 2004
ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017
Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FRJ·January 20, 2016
ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135; (b) Model 136 Forced air dryer for medical devices
FDA Recall
Terminated
·Cenorin, LLC·Product code JRJ·June 7, 2017