10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FORTEC MI-100, BLOOD PRESSURE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
Greenwald Surgical Company
FDA UDI
GRACE MANUFACTURING, INC.·10801334008949·CNTRL'D DIR. CYSTO. ELECT., ANGULAR TIP
Randox RX Daytona Plus Magnesium (MG)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
FDA 510(k)
FDA Class 2
·Orthopedic
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAIL-STER
FDA Adverse Event
Injury
·Product code HWC·September 16, 2021
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2014
ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·October 8, 2010
EUFLEXXA
FDA Adverse Event
Injury
·BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.·Product code MOZ·December 5, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
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