11 results
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28ms
·
Sources: EU EUDAMED, US FDA
RITTER MODEL J DENTAL CHAIR
FDA 510(k)
FDA Class 1
·Dental
TruLock
FDA UDI
Rmo, Inc.·00885797648013·TRULOCK Primer Activated Adhesive Mini Kit (1ea...
SPECTRUM
FDA UDI
Ortho Arch Company Inc·D90980008417·SPECTRUM STOP CRIMPING PLIER***DISCONTINUED/ WH...
CELL-DYN RUBY ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 17, 2014
CELL GEN LASER, MODEL CG-4000
FDA 510(k)
FDA Class 2
·Physical Medicine
ENRAF-NONIUS SONOPULS 190 SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014
PEAK PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 17, 2012
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code MUZ·August 11, 2010
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013