14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODELS TENS 7000, EMS 7500 AND TWIN STIM
FDA 510(k)
FDA Class 2
·Physical Medicine
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606859·GETINGE / SHAMPAINE 4900/5100B, 5100E 3.25" SOF...
Cordera Hip System Blunt Steinman Pins
FDA UDI
Conformis, Inc.·00810933031244·Blunt Steinman Pins
Defend
FDA UDI
Young Innovations, Inc.·00840326418321·Prophylaxis Paste Medium Mint
RANDOX PREALBUMIN
FDA 510(k)
FDA Class 1
·Immunology
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 6, 2023
QUADRA H CEMENTLESS FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 5, 2013
OPTIBOND FL
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 6, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·July 21, 2008
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 22, 2010
SUPERA SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIP·February 21, 2020
SUPERA SELF-EXPANDING STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NIP·March 3, 2020
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