8 results
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19ms
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Sources: EU EUDAMED, US FDA
DSP OPTION
FDA 510(k)
FDA Class 2
·Radiology
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
FDA 510(k)
FDA Class 2
·Orthopedic
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
UNK - SCREW LOCKING
FDA Adverse Event
Injury
·USA SYNTHES·Product code HWC·February 6, 2013
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 21, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 4, 2011
Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·March 1, 2010
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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