863 results
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14ms
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Sources: EU EUDAMED, US FDA
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Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
FDA Recall
Terminated
·Ameditech Inc·Product code LDJ·August 18, 2020
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) .
FDA Enforcement
Class II
·Terminated·Sarken, Inc.·September 4, 2013
Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
FDA Recall
Terminated
·Fujinon Inc·Product code FDF·March 27, 2006
SPI EASY Abutment. Endosseous dental implant abutment.
FDA Recall
Terminated
·Thommen Medical, AG Hauptstrasse, 87 Waldenburg Switzerland·Product code DZE·April 19, 2007
Hill-Rom 100 Low Bed, Model P3930. AC-powered adjustable hospital bed.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNL·April 20, 2009
Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.
FDA Recall
Terminated
·Linet Americas Inc·Product code FNL·December 8, 2011
Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-386. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
FDA Recall
Terminated
·Cybernet Systems Corp.·Product code DXH·January 23, 2008
Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
FDA Recall
Terminated
·Cybernet Systems Corp.·Product code DXH·January 23, 2008
Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-381. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
FDA Recall
Terminated
·Cybernet Systems Corp.·Product code DXH·January 23, 2008
Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
FDA Recall
Terminated
·Cybernet Systems Corp.·Product code DXH·January 23, 2008
Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
FDA Recall
Terminated
·Respironics, Inc.·Product code DOA·October 15, 2007
Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009
Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
FDA Recall
Terminated
·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code KPR·August 15, 2018
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CHP·February 5, 2020
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CHP·February 5, 2020
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
FDA Enforcement
Class II
·Terminated·Sybron Dental Specialties·September 18, 2013
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
FDA Recall
Terminated
·Sybron Dental Specialties·Product code DYJ·June 6, 2013
AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
FDA Recall
Terminated
·Allesee Orthodontic Appliances·Product code DYJ·February 24, 2014