21 results · 23ms · Sources: EU EUDAMED, US FDA

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RADIUS SNARE

FDA 510(k)
FDA Class 2 ·Cardiovascular

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120214411·Carbide, flame, finishing bur

SATURN BLOOD GLUCOSE MONITORING TEST STRIP

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

JAS CALCIUM (ARSENAZO) REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Calix P PEEK Lumbar System, PLIF Trial

FDA Enforcement
Class II ·Terminated·X Spine Systems Inc·October 26, 2016

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·July 8, 2024

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2013

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·February 16, 2011

HIRES 90K

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC·Product code MCM·March 24, 2008

ID NOW COVID-19 ASSAY

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 13, 2021

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·June 12, 2024

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·July 25, 2022

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·June 19, 2024

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·June 19, 2024

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·June 19, 2024

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·June 19, 2024

ID NOW COVID-19 ASSAY

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 13, 2021

ID NOW COVID-19 ASSAY

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 13, 2021

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Injury ·ABBOTT VASCULAR INC.·Product code MGB·January 13, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012