9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772412471·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK I
Endodontic Hand Instruments
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668606211·Senseus Flexofile Size 006 21mm
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
FDA 510(k)
FDA Class 2
·Microbiology
SIGNAPioneer
FDA 510(k)
FDA Class 2
·Radiology
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 7, 2010
NEXGEN LPS-FLEX ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·December 5, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012