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

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MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated

FDA 510(k)
FDA Class 2 ·Cardiovascular

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776182151·Cobb Curette angled size

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690125471·Modular Knee Stem Pilot 19mm x 100mm

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184003·Integra® Jarit® Cobb Style Bone Curette, 11", H...

SacroFuse

FDA UDI
SPINEFRONTIER, INC.·00190361029472·Ø10MM X 90MM SLOTTED FUSION SCREW, GEN II, SACR...

ScalpelCric

FDA 510(k)
FDA Class 2 ·Anesthesiology

NIGHT SHIFT

FDA 510(k)
FDA Class 2 ·Dental

FASTTAKE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 9, 2002

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 20, 2012

RESERVOIR 3ML

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code FRN·June 11, 2018

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 1, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 1, 2018

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 24, 2008

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

INGENIO

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2013

DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/75MM

FDA Adverse Event
Injury ·SYNTHES ELMIRA·Product code KTT·November 17, 2014

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 22, 2013

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025