15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496071341·STRIPE GAME POLARIS, SIZE XL, NERO, GRADUATED C...
Conmed/Linvatec
FDA UDI
Provision·00810041066077·
Conmed/Linvatec
FDA UDI
Provision·B504OM50713410·
NA
FDA UDI
STERILMED, INC.·10888551020701·SAW BLADE SAGITTAL
INTREX
FDA UDI
Conmed Corporation·10845854008676·INTREX LARGE BONE OSCILLATING SAW BLADE 12.5 X ...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 17, 2022
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DR5000 DEDICATED CHEST X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-CLONMEL·Product code MAF·November 20, 2010
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 22, 2013
PINNACLE SECTOR II CUP 66MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC 1818910·Product code LPH·April 13, 2011
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 8, 2008
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