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

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BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

Delivery Analysis

FDA UDI
ACCURAY INCORPORATED·M65810622130·Software, Delivery Analysis, Version 1.2.1

Ventlab

FDA UDI
VENTLAB, LLC·10889483077450·MDI, Spacer, Rigid, Fluted, Antistatic

Rumor

FDA UDI
Ortho Organizers, Inc.·00190707004552·Rumor .022 LL3 -6T 3A 0O

Rumor

FDA UDI
Ortho Organizers, Inc.·00190707004569·Rumor .022 LL3 HK -6T 3A 0O

GULLIVER AND CLASSE A

FDA 510(k)
FDA Class 1 ·Dental

BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID

FDA 510(k)
FDA Class 2 ·General Hospital

SCP PANEL CENTRIFUGE JMS

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013

SCP PANEL CENTRIFUGE JMS

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014

SCP CONTROL PANEL

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018

CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022

STOCKERT JMS CENTRIFUGAL PUMP SYSTEM

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code NVN·April 16, 2013

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·April 11, 2011

M10 PATIENT MONITOR

FDA Adverse Event
Death ·INVIVO CORPORATION·Product code MHX·June 18, 2008

STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM

FDA Adverse Event
Injury ·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

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