109 results
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19ms
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Sources: EU EUDAMED, US FDA
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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 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
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Recall
Open, Classified
·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023
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
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
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
Stryker Medical Stretcher Model 1105 Prime 5th Wheel A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.
FDA Recall
Terminated
·Stryker Medical Division of Stryker Corporation·Product code INK·July 19, 2011
VERTIER Surgical Table, Catalog #0788-100-001 (Standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.
FDA Recall
Terminated
·Stryker Communications Corp·Product code FQO·July 2, 2008
VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX. Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.
FDA Recall
Terminated
·Stryker Communications Corp·Product code FQO·July 2, 2008
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties.
FDA Recall
Terminated
·Velocity Medical Solutions, LLC·Product code LLZ·July 25, 2013
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
FDA Recall
Terminated
·Orthosensor·Product code ONN·February 4, 2012
Remington Medical, Inc., 8 French-Sheath Only, Size 8 French, Single Use. Ethylene Oxide sterilized.
FDA Recall
Terminated
·Remington Medical Inc.·Product code GWG·June 6, 2005