19 results
·
29ms
·
Sources: EU EUDAMED, US FDA
LENSCHEK
FDA 510(k)
FDA Class 1
·Ophthalmic
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837024888·SOLSTICE Polyaxial Screw Assembly 4.0mm x 22mm
308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECATH VENTRICULAR PACING THERMAL DILUTION CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 23, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·June 5, 2023
IAB: 8 FR - 40 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code DSP·December 3, 2010
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 31, 2013
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·July 18, 2014
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·June 16, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·March 15, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH¿·Product code HRX·May 5, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 11, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 25, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 11, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 24, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 18, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 14, 2023
Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product Number: 500118200. 510k K944522. Qty Dist. - 4,180. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Prostate Stabilization Set
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code IWJ·September 1, 2009