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

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CDX DIGITAL X-RAY IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

HairCheck-DT (PCP)

FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809868227·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

MONOJECT SAFETY NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

HEART 2006

FDA 510(k)
FDA Class 2 ·Cardiovascular

RED DCI-DC3 SENSOR

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·September 15, 2015

RD SET GE - 12

FDA Adverse Event
Malfunction ·Product code DQA·August 13, 2021

MAGELLAN

FDA Adverse Event
Malfunction ·CARDINAL HEALTH, INC.·Product code FMI·September 6, 2023

RADIFOCUS OPTITORQUE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

RD SET DCI

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

25KHZ STRAIGHT TIP

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-INAGI·Product code LFL·April 9, 2013

UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code GKZ·April 6, 2011

VITALITY VR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

RD SET NEO CS-3

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

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

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024