10 results
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26ms
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Sources: EU EUDAMED, US FDA
36-101 XDS111 XENON DELIVERY/TRAP SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
Pearson Zirconia Blocks for Sirona InLab #5102
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724A8605041·
LEONE SPA
FDA UDI
LEONE SPA·08033707032519·WEB 1ST MOLAR BANDS n.LR 4
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746049804·WIRE SS POSTED 018 X 025 28MM FORM I 10/PK
RI Witness Embryology Heated Plate
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
6.2MM TI CLICKXPEDICLE SCR PREASSEMBLED 45MM THRD LENGTH
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·December 6, 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