16 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BECTON DICKINSON SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code MEG·April 16, 2018
E-LIGHT LINE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PR CANNULAS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E. CAM COMPUTER [510(K) K992731]
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SYSTEMS, INC.·Product code IYX·April 20, 2001
E.COM, SYMBIA E
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012
E.CAM
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014
SYMBIA T-SERIES
FDA Adverse Event
Injury
·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·March 7, 2013
KAPPA 900 DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code DXY·August 8, 2014
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 15, 2011
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022