32 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015
Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope.
FDA Recall
Terminated
·Fujinon Inc·January 7, 2011
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 21, 2016
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
FDA Recall
Terminated
·Philips Healthcare·Product code OWB·February 2, 2022
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
FDA Enforcement
Class II
·Terminated·Teleflex Medical·August 24, 2016
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
FDA Recall
Terminated
·Teleflex Medical·Product code HCF·November 16, 2016
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
FDA Recall
Terminated
·Teleflex Medical·Product code HCF·March 24, 2016
Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Recall
Terminated
·Westmed, Inc.·Product code KGB·November 11, 2020
Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code MUJ·September 28, 2015
Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·November 7, 2018
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
FDA Enforcement
Class II
·Terminated·NewDeal SA·July 25, 2018
First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.
FDA Recall
Terminated
·Allied Healthcare Products Inc·Product code ECX·May 15, 2009
Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
FDA Recall
Terminated
·Western Scott Fetzer Company·Product code ECX·August 15, 2019