12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUBCUTANEOUS NEEDLE INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
Sterilance Press4 Pressure Activated Safety Lancet
FDA UDI
SteriLance Medical (Suzhou) Inc.·16945630108980·Sterilance Press4 Pressure Activated Safety Lan...
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
FDA 510(k)
FDA Class 2
·Orthopedic
BD ULTRA-FINE¿ INSULIN SYRINGE
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·December 28, 2015
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·April 29, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 29, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·July 24, 2008
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018