10 results
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16ms
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Sources: EU EUDAMED, US FDA
WEEVAC 1 PORTABLE RESCUE STRETCHER
FDA 510(k)
FDA Class 1
·General Hospital
LEADER
FDA UDI
Cardinal Health 110, Inc.·00096295124033·Advanced Antibacterial Clear Waterproof Strong ...
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112439·3M™ Victory Series™ First Molar Bands, 902-474,...
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
FLAATZ 750E
FDA 510(k)
FDA Class 2
·Radiology
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code NVY·July 9, 2015
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·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