10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TDX REA LACTIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641974·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...
GMK UNI
FDA 510(k)
FDA Class 2
·Orthopedic
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
10MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·December 31, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
DIRECT DRIVE CLIP APPLIER 10MM 3/BOX
FDA Adverse Event
APPLIED MEDICAL·Product code FZP·December 4, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS·Product code JAA·June 19, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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