14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
THE GOLDEN QUAD TEST (HSV)
FDA 510(k)
FDA Class 2
·Microbiology
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108093·JAFFE NEEDLE HOLDER CURVED WITH LOCK
Impression Tray
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746035036·SUPPLIES - IMPRESSION TRAY INTRODUCTORY KIT 120...
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746032660·SUPPLIES - IMPRESSION TRAY INTRODUCTORY KIT 120...
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162923·SUPPLIES - IMPRESSION TRAY INTRODUCTORY KIT 120...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861120220·Standard Band, Tooth 44/34, Size 20/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861120000·Standard Band, Tooth 45-44/34-35, Size 20
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011861120180·Standard Band, Tooth 44/34, Size 20/Roth 18
SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
SMR TT Metal Back Glenoid, Bone Graft instruments
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 10, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·October 4, 2010
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 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