19 results · 22ms · Sources: EU EUDAMED, US FDA

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CODMAN SKULL CLAMP

FDA 510(k)
FDA Class 2 ·Neurology

PROFYLE

FDA UDI
Stryker GmbH·34546540244278·BONE SCREWS, CROSS-FIT, SELF-TAPPING

PROFYLE

FDA UDI
Stryker GmbH·07613153152217·Lid For Sterilizing Container

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...

PhoeniX

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO A620 EEG

FDA 510(k)
FDA Class 2 ·Neurology

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·November 4, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS LLC (PR)·Product code NIQ·November 4, 2011

HOLDING SLEEVE-LONG FOR MATRIX

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code LXH·September 18, 2013

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·May 18, 2015

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 1, 2010

HERO GRAFT

FDA Adverse Event
Injury ·HEMOSPHERE, INC.·Product code DSY·January 11, 2013

S-ROM M HEAD 36MM +6

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. REG. # 8010379·Product code LPH·July 3, 2014

2.0 SYSTEM 2.0/1.0 4 HOLE XLONG PLATE

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·April 26, 2024

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·July 27, 2015

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS LLC (PR)·Product code NIQ·November 4, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS LLC (PR)·Product code NIQ·November 4, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Death ·CORDIS LLC (PR)·Product code NIQ·November 4, 2011

Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

FDA Enforcement
Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024