18 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Neoprobe GDS Control Unit, Model Number NPCU3
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code IZD·September 7, 2020
Neoprobe GDS Control Unit, Model Number NPCU3
FDA Enforcement
Class III
·Terminated·Devicor Medical Products Inc·October 14, 2020
Genairex Securi-T Ostomy Deodorant (8 oz, 1 oz package sizes)
FDA Recall
Terminated
·BioMed Laboratories·Product code GDS·August 16, 2010
Reliamed Odor Eliminator Drops (8 oz, 4 oz, 1 oz package sizes)
FDA Recall
Terminated
·BioMed Laboratories·Product code GDS·August 16, 2010
Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)
FDA Recall
Terminated
·BioMed Laboratories·Product code GDS·August 16, 2010
Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.
FDA Recall
Terminated
·Intermed Gas Products Corporation·Product code ECX·March 27, 2009
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Recall
Terminated
·On Site Gas Systems Inc.·Product code CAW·December 19, 2013
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Enforcement
Class II
·Terminated·On Site Gas Systems Inc.·January 15, 2014
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Enforcement
Class II
·Terminated·Linde Gas North America Llc·June 26, 2013
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
FDA Recall
Terminated
·Pentax of America Inc·Product code FDS·August 15, 2016
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
FDA Recall
Terminated
·Fujinon Inc·Product code FDS·July 31, 2013
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FDS·February 17, 2017
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Recall
Terminated
·Pentax Medical Company·Product code FDS·June 12, 2014
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall
Terminated
·Pentax Medical Company·Product code FDS·April 6, 2016
Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FDS·October 16, 2020
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate
FDA Recall
Terminated
·Roche Diagnostics Operations, Inc.·Product code CDS·October 31, 2016
Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FDS·October 16, 2020
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
FDA Recall
Terminated
·Linde Gas North America Llc
575 Mountain Ave
Attn Import Compliance Manager
New Providence NJ 07974·Product code CAN·March 8, 2013