20 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Remedy® Shoulder Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
Acetabular Reamers 67 mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073053·
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121522670·Bridgeback Acetabular Reamer, Size 67mm
ELECSYS FERRITIN CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SUPERCATH V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·June 3, 2019
VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code NIN·June 7, 2013
COMPACT LOW IMPEDANCE LEAD
FDA Adverse Event
Malfunction
·MPROC, VILLALBA·Product code LGW·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·March 30, 2023
HERMETIC LUMBAR CATHETER, CLOSED TIP
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·September 26, 2016
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·July 24, 2019
TIBIAL INSERT FB SZ 3 RT 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·April 13, 2023
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·March 25, 2019
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023