16 results · 25ms · Sources: EU EUDAMED, US FDA

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EndoClot

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

ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

MEMOMETAL INTRA-MEDULLARY BONE FASTENER

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTP·June 11, 2013

X3 TRIATHLON CS INSERT #5 9MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·July 7, 2011

PERIPHERAL CUTTING BALLOON

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code LIT·September 16, 2008

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·May 17, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 18, 2019

OPTILITE SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·June 5, 2020

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 12, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 18, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·November 4, 2022

OPTILITE SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 13, 2020

5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·June 22, 2018

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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