9 results
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24ms
·
Sources: EU EUDAMED, US FDA
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112484·3M™ Victory Series™ First Molar Bands, 902-479,...
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
FDA 510(k)
FDA Class 2
·Radiology
BIOMESH P1 AND BIOMESH PLUG AND PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PULSE GEN MODEL 104
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 30, 2014
DUROM US ACETABULAR COMPONENT 52/46 L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·November 11, 2010
2.4MM LCP DISTAL RADIUS T-PLATE 3H HEAD/4H SHAFT
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·January 8, 2013
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