110 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·December 24, 2014
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code KWD·November 6, 2014
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GFD·August 4, 2020
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GFD·August 4, 2020
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GFD·August 4, 2020
Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
FDA Recall
Terminated
·Integra Lifesciences Sales Llc·Product code KYJ·November 4, 2019
CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). Manufactured by: Invacare Corp., 2101 East lake Mary Blvd. Sanford, FL 32773. Affected bed package model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA,
FDA Recall
Terminated
·Invacare Corporation·Product code FMW·October 11, 2007
Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 0788100001 Standard table with 5th wheel, 0788100000S SIDNE-enabled standard table, and 0788100001S SIDNE-enabled 5th wheel table
FDA Recall
Terminated
·Stryker Communications Corp·Product code FQO·November 13, 2008
Prime 5th Wheel Stryker Medical Stretchers Model 1105 Intended to transport patients in a horizontal position.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code FPO·July 19, 2011
TLC-2000 Therapeutic Medical Laser System
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·April 28, 2020
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·April 28, 2020
TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·February 26, 2020
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Enforcement
Class III
·Terminated·Randox Laboratories, Limited·August 14, 2019
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
FDA Enforcement
Class II
·Terminated·DePuy Spine, Inc.·November 6, 2013
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
FDA Enforcement
Class II
·Terminated·Impac Medical Systems Inc·July 18, 2012
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
FDA Enforcement
Class III
·Terminated·Theralase Inc.·February 26, 2020
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
FDA Recall
Terminated
·DePuy Spine, Inc.·Product code GCC·July 31, 2013
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
FDA Enforcement
Class III
·Terminated·Maquet Cardiovascular Us Sales, Llc·September 23, 2020
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
FDA Recall
Terminated
·Impac Medical Systems Inc·Product code IYE·June 8, 2012