13 results
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27ms
·
Sources: EU EUDAMED, US FDA
SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
Sterile C-Arm / mobile x-ray cover
FDA UDI
Spiggle & Theis Medizintechnik GmbH·04250676717535·for GE 9800, clip system
three ...
N/A
FDA UDI
Smith & Nephew, Inc.·00885554006513·SOD GUAGE DPTH ENDBTN LSR MRKD
CoRoent
FDA UDI
Nuvasive, Inc.·00887517387431·CoRoent XLR Rongeur, Med Dismantlable
SCANLAN® John Ross Tunneler
FDA UDI
SCANLAN INTERNATIONAL INC·00846159035674·SCANLAN® John Ross A/V Access Tunneler, Slight ...
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
FDA 510(k)
FDA Class 2
·Cardiovascular
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
28MM COCR MOD HD +6MM NO SKIRT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 30, 2018
NUVASIVE GENERAL INSTRUMENTS
FDA Adverse Event
Injury
·NUVASIVE, INC.·Product code LXH·April 12, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 27, 2014
UNKNOWN EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·January 8, 2013
TRANSVERSE DRILL GUIDE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code LXI·November 10, 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