9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
D-DI TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809643855·OPAQUE MATERNITY 20-30 MM HG WAIST HIGH ZIG ZAG...
G-scan Brio, S-scan
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES 3.5MM SPRING PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·October 31, 2012
EDWARDS EXPANDABLE INTRODUCER SHEATH SET, 29M
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·June 23, 2015
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