19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Elecsys Cortisol II, Cortisol II CalSet
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII
Geneva
FDA UDI
Nucletron B.V.·08717213056176·Interstitial Ovoid 25mm 1
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019
INFA WARMER I
FDA 510(k)
FDA Class 2
·General Hospital
RESPCARE FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
BASIX COMPAK INFLATION SYRINGE KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·March 14, 2011
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
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 7, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
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
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