10 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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VPS Impression Material
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
Smith & Nephew, Inc.·00885556602478·MTO ACCESSORY CABLE UP5000 TO
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 12, 2021
ALBUMIN COBALT BINDING TEST (ACB TEST)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
FDA 510(k)
FDA Unclassified
·Unknown
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
NOT KNOWN
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC.·Product code LJS·September 25, 2008
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 3, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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