13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
LOW FLOW N2O/02O MICROBLENDER
FDA 510(k)
FDA Class 2
·Anesthesiology
RMO
FDA UDI
Rmo, Inc.·00885797100122·REMOV QUADHELIX KIT
7MM BONE DOWEL PLUNGER
FDA UDI
Biomet Orthopedics, LLC·00880304401716·
Bone Dowel Plunger
FDA UDI
Biomet Orthopedics, LLC·00887868510779·
Lower Crown Pack for Herbst LL5 12mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199007220·
NA
FDA UDI
Synthes GmbH·10886982256331·1.25MM THREADED GUIDE WIRE 150MM
UNIPOLAR NEEDLES
FDA 510(k)
FDA Class 2
·Anesthesiology
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MASUNAGA since 1905
FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644463503·
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2014
COMPLETE SE ILIAC
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIO·January 8, 2013
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·November 16, 2010
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·October 1, 2014