224 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES CERVIFIX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450202920·
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
FDA 510(k)
FDA Class 2
·Cardiovascular
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
FDA 510(k)
FDA Class 2
·Neurology
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 1, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 27, 2007
ULTRASAFE X100L PNG CLEAR NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·February 5, 2021
ULTRASAFE X100L PNG RASPBERRY NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·February 10, 2020
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.
FDA Enforcement
Class II
·Terminated·SpineFrontier, Inc.·August 21, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 14, 2011
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWF·March 12, 2008
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQY·December 28, 2006
ULTRASAFE X100L PNG RASPBERRY NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·January 26, 2021
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 5, 2007
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 28, 2006
BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·September 19, 2018
ULTRASAFE X100L PNG CLEAR NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 24, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 26, 2019
ULTRASAFE X100L PNG RASPBERRY NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·March 19, 2019