9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ESOPHAGEAL INTUBATION DETECTOR BULB
FDA 510(k)
FDA Class 2
·Anesthesiology
CS 7600 Hygienic Sheath
FDA UDI
CARESTREAM DENTAL LLC·40192155942620·CS 7600 HYG SHEATHS SIZE 1 200 PCS
Care Stream Dental
FDA UDI
DuPhaMed B.V.·08717228442650·Hygienic sheaths CS 7600 for phosphor plate size 1
MODIFICATION TO: RADIANALYZER, MODEL 12711
FDA 510(k)
FDA Class 2
·Cardiovascular
Acuson SC2000 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
2.7MM 30° C-MOUNT A/C ARTHROSCOPE W/ LIGHTPOST AT 45° ANGLE
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY-SAN JOSE·Product code HRX·February 4, 2013
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 30, 2010
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 17, 2014
PKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. 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