9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LASERBRUSH
FDA 510(k)
FDA Class 2
·Physical Medicine
HemoCue® Hb 801 Analyzer
FDA UDI
Hemocue AB·07311091219206·HemoCue Hb 801 Analyzer g/dL
VENTRIO ST HERNIA PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
7.0 FR. ENDOBRONCHIAL BLOCKER
FDA 510(k)
FDA Class 2
·Anesthesiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 21, 2013
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 9, 2011
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 13, 2008
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
FDA Enforcement
Class I
·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024