11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609966·MIDMARK 5.25" SOFTCARE PLUS
E-Z EM PERCUPUMP 2001 CT INJECTOR
FDA 510(k)
FDA Class 2
·Radiology
VERSABOND BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
NV GXL LINER NEUTRAL
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LZO·August 9, 2023
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·April 26, 2013
ALLURA XPER FD10 C
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·April 14, 2011
MINILOC
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code FMI·July 9, 2008
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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