22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740822550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674082255060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0822550·8mm H x 22mm W x 55mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X082255120·8mm H x 22mm W x 55mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08225580·8mm H x 22mm W x 55mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L082255120·8mm H x 22mm W x 55mm L XLIF Trial 12 degree Lo...
Zavation
FDA UDI
Zavation LLC·00842166150614·8x22x55mm, 6°, MILC
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120979·ZEUS®-L Implant, 8 x 22 x 55mm, Lordotic
Zavation
FDA UDI
Zavation LLC·00842166149861·8x22x55mm, 0°, MILC
ZEUS-L
FDA UDI
SPINAL ELEMENTS·00840916120986·ZEUS®-L Implant, 8 x 22 x 55mm, Parallel
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
FDA 510(k)
FDA Class 2
·Anesthesiology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 4, 2024
T25 STARDRIVE SHAFT F/MATRIX LONG
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HXX·April 29, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·May 9, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·July 24, 2008
CORIN METAFIX HIP STEM
FDA Adverse Event
Injury
·CORIN MEDICAL·Product code LZO·September 6, 2022
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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