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

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ZOLL CODE WRITER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Sonic

FDA UDI
Sonic Innovations, Inc.·05711583024202·BL100 ITCD, L BE BLISS 100

WU'S 3-WHEELED NEO SCOOTER, WT-T3D

FDA 510(k)
FDA Class 2 ·Physical Medicine

APEX SPINE SYSTEM W/ COCR RODS

FDA 510(k)
FDA Class 2 ·Orthopedic

TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code DRA·January 31, 2024

CAPTIFLEX?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·May 29, 2013

INTELLIVUE MP5

FDA Adverse Event
Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 8, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

MYSPINE STANDARD DRILL GUIDE T07

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019

G4 STEERABLE GUIDING CATHETER (CE)

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code DRA·March 13, 2024

MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL·Product code NKM·April 8, 2024

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024