13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
Magnum Medical
FDA UDI
MAGNUM MEDICAL, INC.·00810025360221·Plastic Twzrs
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
FDA 510(k)
FDA Class 2
·Physical Medicine
NO STEP ON SITE DEUG TEST CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 7, 2012
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 3, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SAO PAULO·Product code KDJ·April 12, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·May 23, 2008
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
ARTEK CUP ME 38/46
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 5, 2019
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code DQA·March 19, 2014
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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