62 results · 34ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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