2,946 results · 23ms · Sources: EU EUDAMED, US FDA

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Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1

FDA 510(k)
FDA Class 2 ·Cardiovascular

ECHO BI-METRIC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304463035·

Bernafon

FDA UDI
Bernafon AG·05711584086933·ZR3, KIT 312 NFM L BE ZERENA 3

Echo® Bi-Metric® Hip System

FDA UDI
Biomet Orthopedics, LLC·00887868260506·

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM

CONAIR

FDA Adverse Event
Malfunction ·CONAIR CORPORATION·Product code IRT·September 26, 2019

RESTORATION ACETABULAR WEDGE AUGMENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

MODEL 1014 PC ELECTROMETER

FDA 510(k)
FDA Class 2 ·Radiology

UNKNOWN DEPUY LINER

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·October 6, 2008

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 4, 2011

MONARC SLING SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·June 20, 2013

HEARTSTART HOME

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code NSA·November 21, 2019

ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

FDA Adverse Event
Malfunction ·ZYNO MEDICAL, LLC·Product code FRN·September 14, 2019

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 11, 2019

NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code MCM·June 18, 2019

COCHLEAR IMPLANT MODEL CI512 WITH CONTOUR ADVANCE ELECTRODE

FDA Adverse Event
Malfunction ·COCHLEAR LTD·Product code MCM·June 19, 2019

CADD SOLIS VIP PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·October 17, 2019

50CM IMPLANT LEAD KIT, SLIM TIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·May 2, 2019

BIA400 IMPLANT 4MM W ABUTMENT 8MM

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·November 18, 2019

V60 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 19, 2019