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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O. B. PACK III
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111883·3M™ Victory Series™ First Molar Bands, 902-273,...
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
RANDOX ETHANOL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·June 25, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·January 8, 2013
SYNCRHOMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 15, 2010
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
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