15 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CALCIUM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CALCIUM

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020

LIQUISPX LIQUID LIPID CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EEA 28MM SINGLE-USE STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·June 1, 2015

EEA31

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 31, 2015

PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*

FDA Adverse Event
Injury ·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GDW·November 4, 2015

COBAS INTEGRA 800

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 17, 2013

IMMULITE 2500 OMMA (CA125)

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS LTD.·Product code LTK·June 18, 2008

DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·April 19, 2011

DST SERIES ORVIL AUTOMATIC 25MM DEVICE

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·April 25, 2016

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 12, 2022

EEA 31MM SINGLE-USE STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·December 11, 2015

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015