14 results · 24ms · Sources: EU EUDAMED, US FDA

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Blue Sky Bio Zygomatic Implant System

FDA 510(k)
FDA Class 2 ·Dental

Oticon

FDA UDI
Oticon A/S·05707131338945·SIYA 2, BTE 13 PP 2.4G 105 C091

COMPOSITCP RESORBABLE INTERFERENCE SCREW

FDA Adverse Event
Malfunction ·S.B.M. SAS·Product code HWC·October 4, 2021

BACKSTOP CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DSS STABILIZATION SYSTEM-RIGID

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 11, 2024

INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 16, 2024

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 21, 2014

MERIT CUSTOM KIT

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·June 21, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

MAMBA? FLEX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

FDA Enforcement
Class II ·Completed·SCIENCE & BIO MATERIALS·July 20, 2022

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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