18 results · 33ms · Sources: EU EUDAMED, 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