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

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TRIAGE D-DIMER TEST, MODEL 98100

FDA 510(k)
FDA Class 2 ·Hematology

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·May 11, 2018

TRIAGE PROFILER SOB PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

TRIAGE PROFILER SOB PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

TRIAGE D-DIMER TEST

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·October 2, 2019

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·September 17, 2019

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·May 7, 2019

TRIAGE D-DIMER PANEL

FDA Adverse Event
Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·August 17, 2018

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074033532·BONE SCREW 7042890 20 DEG ILC 8.5X90 TI

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·10304040060206·Disposable Prophy Angle LF

MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

FDA 510(k)
FDA Class 2 ·Dental

INTRALASE 600C LASER KERATOME

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TILOCK PEDICLE SCREW SYSTEM

FDA Adverse Event
Malfunction ·GENESYS SPINE·Product code NKB·April 4, 2013

INTELLIVUE MP2

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 30, 2011

VITALITY 2 DR

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

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