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

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IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

FDA 510(k)
FDA Class 2 ·Immunology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517403216·CoRoent® XL, 8x18x55mm 10°

Modulus Expandable

FDA UDI
Nuvasive, Inc.·00195377056030·MOD-EX PL Funnel Stand, Graft Delivery

CLYDESDALE PTC™ Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169190757·CAGE 4980855 CDALE PTC 18MM 0 DEG 8X55

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376301594·Tap, Thoracic, 5.5mm

Invictus

FDA UDI
ALPHATEC SPINE, INC.·00190376309651·Tap, Thoracic, 5.5mm, Navigation

Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GAMMA CAMERA

FDA 510(k)
FDA Class 1 ·Radiology

IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

FDA Adverse Event
Injury ·ABIOMED, INC. - 1220648·Product code OZD·January 19, 2026

PREVENA PLUS INCISION MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·February 27, 2013

ADVIA CENTAUR

FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·February 7, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014

NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: NUVASIVE COROENT THORACOLUMBAR SYSTEM,

FDA Adverse Event
Malfunction ·NUVASIVE INC.·Product code MAX·August 25, 2022