62 results
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34ms
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Sources: EU EUDAMED, US FDA
MEDAICA INC
FDA registration
MEDAICA INC·1 product·🇺🇸 United States
SULZER MEDICA SULZER ORTHOPEDICS INC.
FDA Adverse Event
Injury
·SULZER AKA ZIMMER·Product code JWH·August 3, 2004
EPIDURAL CATHETER BRAUN
FDA Adverse Event
Injury
·BRAUN MEDICA, INC.·Product code LMP·January 19, 1995
PKS OMNI
FDA Adverse Event
Injury
·GYRUS MEDICA, INC.·Product code GEI·May 29, 2013
MERCI BALLOON GUIDE CATHETER 9F X 95 CM
FDA Adverse Event
Malfunction
·CONCENTRIC MEDICA, INC.·Product code DQY·September 16, 2011
TREADMILL
FDA Adverse Event
MARQUETTE MEDICA,INC.·Product code IOL·May 3, 1995
CENTURION MIXER
FDA Adverse Event
Malfunction
·MATRIX MEDICA, INC.·Product code BSZ·March 23, 1998
TriFoillmaging Triumph/Triumph II Research CT scanners.
FDA Enforcement
Class II
·Terminated·Northridge Tri-Modality Imaging,·October 12, 2016
18 GAUGE BLUNT FILL HYPO NEEDLE
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICA, INC.·Product code LHI·March 6, 2024
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Enforcement
Class I
·Terminated·Nephros Inc·December 25, 2013
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
FDA Enforcement
Class I
·Terminated·Nephros Inc·December 25, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICA, INC. CRMD·Product code NVY·January 13, 2014
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICA, INC CRMD·Product code DXY·January 13, 2014
EQUA SMART
FDA Adverse Event
Malfunction
·MEDICA USA INC.·Product code KDI·November 16, 2023
VIEWFLEX CATHETER, XTRA ICE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICA, INC. (AF-IRVINE)·Product code IYO·October 8, 2013
INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICA SYSTEMS, INC.·Product code FHW·January 10, 1997
MEDFUSION 4000 PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICA ASD, INC.·Product code FRN·November 27, 2024
PHILLIPS MEDICAL SYSTEMS -CLEV- INC. FORMERLY PICKER INTERNA
FDA Adverse Event
Malfunction
·PHILLIPS MEDICA SYSTEMS -CLEV- INC.·Product code KXJ·September 23, 2002
SULZER
FDA Adverse Event
Injury
·SULZER MEDICA, SULZER ORTHOPEDICS, INC·Product code LPH·October 29, 2001
SULZER IMPLANT
FDA Adverse Event
SULZER MEDICA, SULZER ORTHOPEDICS INC·Product code LPH·October 29, 2001