24 results
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22ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752114845·AirLife™ Misty Max 10™ Nebulizer With 7 foot (2...
AirLife™
FDA UDI
AIRLIFE·10889483571088·AirLife™ Misty Max 10™ Nebulizer With 7 foot (2...
AirLife
FDA UDI
Carefusion Corporation·10885403006562·Airlife™ Misty Max 10™ Nebulizer Wi...
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862161642·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361009030·PedFuse Reset, CNL, 8.0mm x 35mm
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
SURGITEK ADJUSTABLE RECONSTRUCTIVE BILUMEN IMPLANT
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code FTR·June 10, 1994
SURGITEK GEL-FILLED IMPLANT
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code FTR·June 10, 1994
SURGITEK SILICONE IMPLANT
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code FTR·June 10, 1994
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
VIKING OPTIMA GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SLEEPSTRIP DISPOSABLE APNEA SCREENER
FDA 510(k)
FDA Class 2
·Anesthesiology
QUICK COUPLING FOR DRILL BITS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 13, 2013
ASR ACETABULAR IMPLANT 52?
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 12, 2014
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·March 26, 2026
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016