64 results · 21ms · Sources: EU EUDAMED, US FDA

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AIO HD OTOSCOPE

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM

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

GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 21, 2019

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025

REVOLUTION CMS W/BRK FEM NZL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-PUERTO RICO·Product code JDZ·May 22, 2013

DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDI·September 26, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

PROSOUND F75 ULTRASOUND SCANNER

FDA Adverse Event
Malfunction ·HITACHI ALOKA MEDICAL, LTD·Product code GXX·July 16, 2014

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

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 14, 2018

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2016

Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·April 30, 2014

GMK-REVISION FEMUR REVISION PS SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019

GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2018

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2018

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2024

GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 28, 2019

GMK-REVISION 02.07.0310SCF FIXED TIBIAL INSERT SC SIZE 3/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 10, 2024