12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
FDA 510(k)
FDA Class 2
·Orthopedic
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
HIROLLER ELEVATING WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 24, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
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 L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025