11 results
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35ms
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Sources: EU EUDAMED, US FDA
STRYKER 5050 STRECHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150751·K-WIRE - SINGLE TROCAR 1.25mm DIA x 200mm
MEDEOR MATRIX WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
FDA 510(k)
FDA Class 2
·General Hospital
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·December 20, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·December 27, 2012
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010
PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 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