9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLAROX
FDA 510(k)
FDA Class 2
·Dental
BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood and Levine EMB Agar I Plate™
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902212864·BD BBL™ Trypticase™ Soy Agar with 5% Sheep Bloo...
EPIC 10
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
FDA 510(k)
FDA Class 2
·Radiology
LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 3, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 28, 2013
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·August 17, 2011
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