10 results
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17ms
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Sources: EU EUDAMED, US FDA
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809641691·OPAQUE MATERNITY 15-20 MM HG THIGH HIGH ZIG ZAG...
REAMER SHAFT, AO FITTING ?8,0X448 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 7, 2011
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·December 7, 2012
AVANCE FOAM DRESSING KIT (MEDIUM)
FDA Adverse Event
Malfunction
·MOLNLYCKE HEALTHCARE·Product code BTA·June 19, 2015
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