16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
VAX-D GENESIS G2 SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MERIDIAN-II AND MERDIAN-PLUS
FDA 510(k)
FDA Class 2
·Neurology
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Injury
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 13, 2020
ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NTE·April 22, 2013
HARMONIC ACE SHEARS 5.5 DIAM.
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code LFL·April 21, 2011
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 8, 2008
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Death
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018
ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
FDA Adverse Event
Malfunction
·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018