27 results · 32ms · Sources: EU EUDAMED, US FDA

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Evolve Nitric Oxide Delivery System

FDA 510(k)
FDA Class 2 ·Anesthesiology

Pinnacle

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010124·Pinnacle .022 MC UL 4/5 HK G/O -7T 0A 0O (10PK)

Votion

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008299·Votion .022 MC UL 4/5 HK G/O -7T 0A 0O (10PK)

Votion®

FDA UDI
Ortho Organizers, Inc.·00190707113988·Votion .022 MC UL 4/5 HK G/O -7T 0A 0O (10PK)

Pinnacle®

FDA UDI
Ortho Organizers, Inc.·00190707112073·Pinnacle .022 MC UL 4/5 HK G/O -7T 0A 0O (10PK)

Restoris Multi-Compartmental Knee System

FDA 510(k)
FDA Class 2 ·Orthopedic

LumiVy Lumbar IBF System

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·July 15, 2011

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 10, 2013

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code JJE·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·November 21, 2012