71 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BIRD AVEA VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
RANDOX MICROALBUMIN
FDA 510(k)
FDA Class 2
·Immunology
SELF-RETAINING SCREWDRIVER FORQUICK LOCK SCREWS 275MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 29, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·April 28, 2011
SWAN-GANZ BIPOLAR PACING CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·July 21, 2008
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC·Product code CBK·October 26, 2009
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022
GLIDESHEATH
FDA Adverse Event
Death
·TERUMO MEDICAL CORPORATION·Product code DYB·September 6, 2023
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·September 28, 2023
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 2, 2021
RADIFOCUS INTRODUCER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 18, 2022