17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRIFIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890105351·Zirlux Implant Analog
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150869·Endo Carry-on Procedure Kit contains Intercept ...
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033167359·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033167335·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033167366·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033167311·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033167328·
IRONMAN
FDA UDI
FGX INTERNATIONAL INC.·00193033167342·
DRACO
FDA UDI
HNM TOTAL RECON LLC·00841742121888·DRACO MetaFuse BLP Plate, Ti - (L)35mm, R
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
QUANTA LITE LKM-1 ELISA
FDA 510(k)
FDA Class 2
·Immunology
UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM (ACCESS® 2 PORTION)
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·March 19, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·February 25, 2011
GROSHONG ATTACHABLE VENOUS CATHETER
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code LJT·February 15, 2008
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
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015