10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CYTOSET(TM)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Brigade
FDA UDI
Nuvasive, Inc.·00887517455185·Brigade HL Trial, 4x34x24mm 20°
ALLthread Titanium
FDA UDI
Biomet Orthopedics, LLC·00880304453449·
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
THERMOTEX PLATINUM SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·May 9, 2014
QUADRA ASSURA CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC·Product code NQO·November 17, 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