64 results
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21ms
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Sources: EU EUDAMED, US FDA
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