21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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STERIS Kindest Kare Perineal Cleanser Incontinence System, packaged in 4-fl. oz. bottles (72 per case), Ready-To-Use, No-Rinse Solution, For Pediatric and Geriatric Use, For Hospital and Professional Use Only. The label shows the responsible firm to be STERIS Corporation, St. Louis, MO.
FDA Recall
Terminated
·Steris Corportion·Product code JD-01·April 28, 2004
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
FDA Enforcement
Class II
·Terminated·Vygon Corporation·June 20, 2012
microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
FDA Enforcement
Class II
·Terminated·Elekta Limited·April 17, 2019
VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
FDA Recall
Terminated
·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
FDA Recall
Terminated
·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
FDA Recall
Terminated
·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code HMX·December 17, 2019
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
FDA Recall
Terminated
·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019
VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
FDA Enforcement
Class II
·Terminated·Vitreq Bv·February 5, 2020
Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). International Ethidine Corp (ITC)-Nexus Dx. A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011
IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
FDA Recall
Terminated
·International Technidyne Corp.·Product code JPA·May 10, 2011
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
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*. The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.
FDA Enforcement
Class II
·Terminated·Cosman Medical, LLC·February 28, 2018
GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: The Interstitial Plastic Needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles each needle is supplied with a Mandrin
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011