12 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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CHEMVIEW-10
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809866698·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·May 28, 2014
TOKUYAMA REBASE II
FDA 510(k)
FDA Class 2
·Dental
FAS ENDOLUMINAL BRUSH
FDA 510(k)
FDA Class 2
·General Hospital
MARGRON STEM (K032641)
FDA Adverse Event
Injury
·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005
XMAX MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code ERL·April 2, 2013
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·April 6, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 22, 2017
PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019