19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOMATOM FLASH DS
FDA 510(k)
FDA Class 2
·Radiology
PMMA disc
FDA UDI
Dentsply International Inc.·D00180822200·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0822200·8mm H x 22mm W x 20mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L082220120·8mm H x 22mm W x 20mm L XLIF Trial 12 degree Lo...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08222080·8mm H x 22mm W x 20mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X082220120·8mm H x 22mm W x 20mm L x 12 degrees XLIF
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
FDA 510(k)
FDA Class 1
·General Hospital
TAO EMBRYO TRANSFER CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NEURON DELIVERY CATHETER 053
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·March 16, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code JOH·November 18, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·December 9, 2010
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·February 1, 2011
2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code FZX·April 29, 2013
DYONICS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY·Product code HRX·April 22, 2011
UF 30G 1/2 CC SYRINGE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMF·July 25, 2008
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code FZW·April 1, 2019
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018