12 results
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27ms
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Sources: EU EUDAMED, US FDA
S-TEST C-REACTIVE PROTEIN (CRP)
FDA 510(k)
FDA Class 2
·Immunology
Non-Locking Screw, 2.7mm x 40mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026429·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450287958·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130400·ROD REDUCER, AXIAL
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044206890·MINI SURETY COLUMN I
LIGHT SABER INTRODUCER NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 29, 2013
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·May 5, 2011
LIGAMAX- 5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 23, 2008
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