9 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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ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111814·3M™ Victory Series™ First Molar Bands, 902-266,...
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX METHAMPHETAMINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RESTYLANE L, RESTYLANE LIDOCAINE
FDA Adverse Event
Injury
·Q-MED·Product code LMH·June 25, 2014
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
UNKNOWN·Product code FNL·January 8, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 15, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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