16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REHASTIM 2, REHAMOVE 2
FDA 510(k)
FDA Class 2
·Neurology
2870 3WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00817136020259·2870C C OUT/IN,A BAG,W/FE LUER
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005094·GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 15mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005117·GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 21mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005131·GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 44mm x 21mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005100·GLOBAL ADVANTAGE HUMERAL HEAD SIZE 44mm x 18mm
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295005124·GLOBAL ADVANTAGE ECCENTRIC HEAD SIZE 44mm x 18mm
ALL-BOUND 3
FDA 510(k)
FDA Class 2
·Dental
MAROSIS PACS
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
UNKNOWN DEPUY CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 18, 2011
DEFINIUM 8000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS, LLC·Product code KPR·August 13, 2008
INSPIRE HVR DUAL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTN·November 12, 2024
INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·November 18, 2022
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