185 results
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14ms
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Sources: EU EUDAMED, US FDA
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Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·April 25, 2018
Halyard Closed Suction System for Adults, Multi-AccessPortClosedSuctionSystemforAdults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;
FDA Recall
Terminated
·Halyard Health, Inc·Product code BSY·February 7, 2018
Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
FDA Recall
Terminated
·Puritan Bennett Corporation·Product code MNT·August 31, 2006
Diagnost 96/97 DSI
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·September 9, 2015
KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·September 9, 2015
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
General X-Ray System types with Digital Spot Imaging (DSI) software
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZJ·May 23, 2008
KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Recall
Terminated
·Halyard Health, Inc·Product code BSY·July 29, 2015
KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Recall
Terminated
·Halyard Health, Inc·Product code BSY·July 29, 2015
STA Neoplastine CI Plus 10; Product Catalogue Number: 0667 Manufactured by Diagnostica Stago, Asnieres, France.
FDA Recall
Terminated
·Diagnostica Stago, Inc.·Product code GJS·October 20, 2008
STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.
FDA Recall
Terminated
·Diagnostica Stago, Inc.·Product code GJS·October 20, 2008
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography
FDA Recall
Terminated
·Philips North America, LLC·Product code IXR·February 28, 2019
Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXL·January 4, 2008
Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create digital images from an analog system. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXR·January 4, 2008
EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film option and it does not have a Digital Spot Imaging (DSI) system. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXR·January 4, 2008
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DSI·November 8, 2007
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSY·December 7, 2010
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
FDA Recall
Terminated
·Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom·Product code DSY·July 15, 2014