16 results
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22ms
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Sources: EU EUDAMED, US FDA
CELLTRIFUGE II
FDA 510(k)
FDA Class 2
·Hematology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209122066·KIT, MINI MEDIC - MTC - ADVANCED
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016432·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12m...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016449·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 14m...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016463·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 18m...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016456·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16m...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016425·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10m...
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
FDA 510(k)
FDA Class 2
·General Hospital
T-STAT 303 ISCHEMIA MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 8, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·October 17, 2012
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·August 16, 2010
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
FDA Enforcement
Class II
·Terminated·Nipro Diagnostics, Inc.·February 12, 2014
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
FDA Enforcement
Class II
·Terminated·Nipro Diagnostics, Inc.·April 24, 2013
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·July 1, 2020
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