18 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V60 Anesthetic Vaporizer
FDA 510(k)
FDA Class 2
·Anesthesiology
A7 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017
Oticon
FDA UDI
Oticon A/S·05707131285867·H15V2, RITE 312 WL SGR
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120540·Guidewire 1.6x150mm Dbl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120557·Guidewire 1.6x150mm Sgl Trocar
Tibial Post Drill
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073749·
CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
FDA 510(k)
FDA Class 2
·Radiology
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
SYNCHROMED EL
FDA Adverse Event
Death
·RICE CREEK MANUFACTURING·Product code LKK·September 3, 2008
PEDIASAT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DRE·December 10, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DQE·March 27, 2025
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXG·January 7, 2025
BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 18, 2022
BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 23, 2022
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015