14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189737·LEVAMED ACTIVE ANKLE SUP BLACK L IV
TIGER Spine System
FDA UDI
CORELINK LLC·M7256031524·POSTED SCREW PLATE - 1 SLOT - 24.5MM
TIGER Spine System
FDA UDI
CORELINK LLC·M72560315240·POSTED SCREW PLATE 1 SLOT 24.5MM
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMMEDIATE STABILIZING DEVICE (ISD)
FDA 510(k)
FDA Class 2
·Dental
1.1MM NON-THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES ELMIRA·Product code FZX·April 2, 2013
SECURE 2 MED/SURGBED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 21, 2011
9616240-2008-00020
FDA Adverse Event
Malfunction
·Product code KDI·March 31, 2008
TUBING SET, IRRIGATION, FC
FDA Adverse Event
Injury
·KARL STORZ SE & CO. KG·Product code HIF·June 27, 2023
TUBING SET, IRRIGATION, FC
FDA Adverse Event
Malfunction
·KARL STORZ SE & CO. KG·Product code OCX·November 25, 2024
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013