15 results · 28ms · Sources: EU EUDAMED, US FDA

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GRAVITY™ Syndesmosis LP

FDA 510(k)
FDA Class 2 ·Orthopedic

FLEXCATH ADVANCE STEERABLE SHEATH

FDA Adverse Event
Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·August 2, 2016

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

TROJAN PLEASURE PACK LUBRICATED CONDOMS

FDA Adverse Event
Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 14, 2013

CONTAK RENEWAL

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

FDA Adverse Event
Malfunction ·BIOENTERICS CORPORATION·Product code LTI·September 10, 2008

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025

GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023

GMK-HINGE FEMORAL COMPONENT SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022

GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019

Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

FDA Enforcement
Class II ·Terminated·Vision RT Ltd·October 10, 2018

Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

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