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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TITAN ZODIAC ADJUSTING TABLE
FDA 510(k)
FDA Class 1
·Physical Medicine
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113493·LAMELLAR BLADE #66-60 (BX/5)
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112354·3M™ Victory Series™ First Molar Bands, 902-466,...
ACTICOAT COMPOSITE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·May 7, 2014
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 8, 2013
DUROM US ACETABAR COMPONENT 60/54 T
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·November 10, 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