70 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA 510(k)
FDA Class 2
·Cardiovascular
STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA Adverse Event
Other
·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
2520274-2013-02245
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2011
TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·July 23, 2008
H 105700#TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015
HQV 32902#INTEGRATED ADULT PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015
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