104 results · 12ms · Sources: EU EUDAMED, US FDA

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The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle stimulator. The RS-FBG is a prescription device for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments. The device is sold individually in several variations for size. It is fitted to the patient and an RS Medical employee gives the patient instructions on how to utilize the device with proper electrode placement in conjunction with the respective TENS/muscle stimulator.

FDA Recall
Terminated ·International Rehabilitative Sciences, Inc.·Product code GXY·May 17, 2010

PICC Tray, STERILE, 12 packs each per case.

FDA Recall
Terminated ·Medline Industries, Inc.·Product code N/A·April 12, 2017

Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.

FDA Recall
Terminated ·Medline Industries, Inc.·Product code N/A·April 12, 2017

LASER CDS

FDA Recall
Terminated ·Medline Industries, Inc.·Product code N/A·April 12, 2017

Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code OXQ·December 11, 2019

Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B

FDA Recall
Terminated ·Medical Action Industries, Inc.·Product code PEZ·April 9, 2021

Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800 TRAY,PORT-A-CATH ACCESS DYNDC1855A CVC DRESSING CHANGE KIT DYNDC1870A SMALL DRESSING KIT DYNDC1945B PORT ACCESS KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1996B CENTRAL LINE DRESSING CHANGE DYNDC2004A IVAD KIT DYNDC2063D CENTRAL LINE DRESSING KIT DYNDC2063D CENTRAL LINE DRESSING KIT DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2078 VAD DRESSING CHANGE TRAY DYNDC2122B NEONATAL DRESSING CHANGE TRAY DYNDC2208C PEDIATRIC CENTRAL LINE SMALL DYNDC2215 DRESSING CHANGE W/CHG DYNDC2253 CENTRAL LINE DRESSING CHANGE DYNDC2278 CENTRAL LINE DRESSING CHANGE DYNDC2279 A LINE DRESSING CHANGE DYNDC2325A CVC DRESSING CHANGE DYNDC2338A PORT ACCESS KIT DYNDC2338A PORT ACCESS KIT DYNDC2396 CENTRAL LINE CAP CHANGE KIT DYNDC2451 PORT ACCESS KIT W/SALINE DYNDC2464B PORT DRESSING CHANGE KIT DYNDC2521 DRESSING CHANGE KIT SM LF 1921 DYNDC2523 IMPLANTED PORT ACCESS KIT DYNDC2523 IMPLANTED PORT ACCESS KIT DYNDC2597A PHC IMPLANTED PORT TRAY DYNDC2597A PHC IMPLANTED PORT TRAY DYNDC2625 CNTRL LINE DRSG CHG/PORT KIT DYNDC2639 CENTRAL LINE CANCER CENTER DYNDC2645 LVAD KIT DYNDC2651A CENTRAL LINE/PICC DRSG CHG KIT LARGE DYNDC2691 Angio Port Kit w/High Grade Instruments

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code OXQ·December 11, 2019

Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code LRP·February 20, 2018

Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code LRP·February 20, 2018

Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code LRP·February 20, 2018

Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

FDA Recall
Terminated ·Cardinal Health 200, LLC·Product code LRP·February 20, 2018

microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD.

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·October 31, 2005

FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·March 14, 2005

microTargeting Drive System with Mounted Accessories Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·March 30, 2010

microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

microTargeting" Drive System, Product Number MT-DS-01

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740

FDA Recall
Terminated ·FHC, Inc.·Product code GZL·June 17, 2020

Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·October 31, 2005