14 results
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20ms
·
Sources: EU EUDAMED, US FDA
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARGELOY NP SUPREME 100g
FDA UDI
ARGEN CORPORATION, THE·D818112738·Base metal alloy
OTHER EXTERNAL FIXATION
FDA UDI
Smith & Nephew, Inc.·03596010042507·HEX-FIX ADD-A-CLAMP
LANX FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PASS LP - LIGAPASS
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code JDQ·April 26, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013
PURITAN BENNETT 980 SERIES VENTILATOR
FDA Adverse Event
Malfunction
·MEDTRONIC/COVIDIEN·Product code CBK·September 17, 2025
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·May 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
HERCULES 3 STAGE BALLOON ESOPHAGEAL
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNQ·May 27, 2011
PASS LP - LIAPASS
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025