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